Trial Outcomes & Findings for A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) (NCT NCT02554812)
NCT ID: NCT02554812
Last Updated: 2024-07-30
Results Overview
Severity of AEs graded as per CTCAE v4.03. Phase 1b lead-in, AEs occurring during DLT observation period, that attributable to one or more study drug in combination was classified as DLT: Hematologic: Grade (G)4 neutropenia lasting \>7 day; Febrile neutropenia; Neutropenic infection; G \>=3 thrombocytopenia with bleeding; G4 thrombocytopenia; G4 anemia. Non-Hematologic (Non-Laboratory): Any G3 toxicity, except following: Transient (24 H) G3 fatigue, local reaction, or headache that resolved to G1; G3-4 nausea/vomiting controlled by medical therapy within 72H; G3 hypertension controlled by medical therapy; G3 diarrhea improved to G \<=2 within 72H after medical therapy; G3 skin toxicity resolved to G \<=1 in \<7 days after medical management; G \>=3 amylase or lipase abnormality not associated with pancreatitis;G3 endocrinopathies controlled with medical therapy; Tumor flare phenomenon.G4 or G3 CRS lasting \>24 H despite treatment.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
409 participants
Primary outcome timeframe
Baseline up to Cycle 2 (up to 8 weeks)
Results posted on
2024-07-30
Participant Flow
In this study participants were evaluated in 5 different combinations with avelumab: Combination A, B, C, D and F. Each combination was planned to be conducted in 2 phases: Phase 1b (lead-in phase) and Phase 2 (expansion phase). Phase 2 was conducted at the selected dose level of avelumab combination which was determined safe for participants in Phase 1b.
Participant milestones
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab
During Phase 2 participants with melanoma received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab
During Phase 2 participants with Squamous Cell Carcinoma of the Head and Neck (SCCHN) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with Triple Negative Breast Cancer (TNBC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with Squamous cell lung cancer (SCLC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
|
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received PF-04518600 1.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
|
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab
During Phase 1b participants received PF-04518600 3.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
|
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab
During Phase 2 participants with NSCLC received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
|
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab
During Phase 2 participants with SCCHN received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
|
Combination C Phase 1b: PD 0360324 50 mg + Avelumab
During Phase 1b participants received PD 0360324 50 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination C Phase 1b: PD 0360324 100 mg + Avelumab
During Phase 1b participants received PD 0360324 100 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination C Phase 1b: PD 0360324 150 mg + Avelumab
During Phase 1b participants received PD 0360324 150 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 0.1 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.1 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab
During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 sub-cutaneous \[SC\] administered at weekly intervals, followed by 5 intra tumoral \[IT\] administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W. Phase 2 was not planned.
|
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg
During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus utomilumab 100 mg administered IV Q4W. Phase 2 was not planned.
|
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg
During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus PF-04518600 at 0.3 mg/kg administered IV Q2W. Phase 2 was not planned.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
29
|
28
|
35
|
21
|
10
|
21
|
11
|
11
|
12
|
12
|
8
|
14
|
25
|
10
|
8
|
6
|
12
|
12
|
12
|
12
|
12
|
11
|
6
|
7
|
7
|
|
Overall Study
Treated
|
29
|
27
|
29
|
28
|
35
|
21
|
10
|
21
|
11
|
11
|
12
|
12
|
8
|
14
|
25
|
10
|
8
|
6
|
12
|
12
|
12
|
12
|
12
|
11
|
6
|
7
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
29
|
28
|
29
|
28
|
35
|
21
|
10
|
21
|
11
|
11
|
12
|
12
|
8
|
14
|
25
|
10
|
8
|
6
|
12
|
12
|
12
|
12
|
12
|
11
|
6
|
7
|
7
|
Reasons for withdrawal
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab
During Phase 2 participants with melanoma received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab
During Phase 2 participants with Squamous Cell Carcinoma of the Head and Neck (SCCHN) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with Triple Negative Breast Cancer (TNBC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with Squamous cell lung cancer (SCLC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
|
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received PF-04518600 1.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
|
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab
During Phase 1b participants received PF-04518600 3.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
|
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab
During Phase 2 participants with NSCLC received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
|
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab
During Phase 2 participants with SCCHN received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
|
Combination C Phase 1b: PD 0360324 50 mg + Avelumab
During Phase 1b participants received PD 0360324 50 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination C Phase 1b: PD 0360324 100 mg + Avelumab
During Phase 1b participants received PD 0360324 100 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination C Phase 1b: PD 0360324 150 mg + Avelumab
During Phase 1b participants received PD 0360324 150 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 0.1 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.1 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab
During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 sub-cutaneous \[SC\] administered at weekly intervals, followed by 5 intra tumoral \[IT\] administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W. Phase 2 was not planned.
|
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg
During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus utomilumab 100 mg administered IV Q4W. Phase 2 was not planned.
|
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg
During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus PF-04518600 at 0.3 mg/kg administered IV Q2W. Phase 2 was not planned.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
5
|
3
|
0
|
5
|
0
|
1
|
6
|
2
|
2
|
1
|
2
|
0
|
3
|
2
|
1
|
0
|
1
|
0
|
0
|
0
|
2
|
1
|
1
|
1
|
2
|
1
|
|
Overall Study
Death
|
1
|
2
|
2
|
2
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
1
|
2
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Global deterioration of health status
|
4
|
3
|
3
|
2
|
5
|
0
|
2
|
1
|
1
|
1
|
2
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Progressive disease
|
20
|
16
|
19
|
18
|
21
|
15
|
6
|
13
|
6
|
6
|
8
|
8
|
6
|
10
|
20
|
6
|
3
|
3
|
11
|
7
|
11
|
6
|
9
|
9
|
4
|
5
|
5
|
|
Overall Study
Other
|
0
|
0
|
2
|
3
|
2
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
2
|
2
|
3
|
0
|
0
|
1
|
1
|
0
|
1
|
1
|
1
|
1
|
1
|
3
|
1
|
0
|
2
|
0
|
1
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Study terminated by sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
No longer meets eligibility criteria
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley)
Baseline characteristics by cohort
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=29 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=27 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=29 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab
n=28 Participants
During Phase 2 participants with melanoma received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab
n=35 Participants
During Phase 2 participants with Squamous Cell Carcinoma of the Head and Neck (SCCHN) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab
n=21 Participants
During Phase 2 participants with Triple Negative Breast Cancer (TNBC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab
n=10 Participants
During Phase 2 participants with Squamous cell lung cancer (SCLC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
n=21 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
n=11 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=11 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
|
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received PF-04518600 1.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
|
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab
n=8 Participants
During Phase 1b participants received PF-04518600 3.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
|
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab
n=14 Participants
During Phase 2 participants with NSCLC received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
|
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab
n=25 Participants
During Phase 2 participants with SCCHN received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
|
Combination C Phase 1b: PD 0360324 50 mg + Avelumab
n=10 Participants
During Phase 1b participants received PD 0360324 50 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination C Phase 1b: PD 0360324 100 mg + Avelumab
n=8 Participants
During Phase 1b participants received PD 0360324 100 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination C Phase 1b: PD 0360324 150 mg + Avelumab
n=6 Participants
During Phase 1b participants received PD 0360324 150 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 0.1 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.1 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=11 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab
n=6 Participants
During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 sub-cutaneous \[SC\] administered at weekly intervals, followed by 5 intra tumoral \[IT\] administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W. Phase 2 was not planned.
|
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg
n=7 Participants
During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus utomilumab 100 mg administered IV Q4W. Phase 2 was not planned.
|
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg
n=7 Participants
During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus PF-04518600 at 0.3 mg/kg administered IV Q2W. Phase 2 was not planned.
|
Total
n=408 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.14 Years
STANDARD_DEVIATION 11.22 • n=99 Participants
|
60.74 Years
STANDARD_DEVIATION 10.85 • n=107 Participants
|
61.52 Years
STANDARD_DEVIATION 11.81 • n=206 Participants
|
63.71 Years
STANDARD_DEVIATION 10.82 • n=7 Participants
|
61.09 Years
STANDARD_DEVIATION 11.80 • n=31 Participants
|
53.33 Years
STANDARD_DEVIATION 14.59 • n=30 Participants
|
59.40 Years
STANDARD_DEVIATION 12.74 • n=3 Participants
|
65.24 Years
STANDARD_DEVIATION 11.05 • n=6 Participants
|
65.27 Years
STANDARD_DEVIATION 10.05 • n=114 Participants
|
69.55 Years
STANDARD_DEVIATION 4.06
|
54.17 Years
STANDARD_DEVIATION 12.55 • n=19 Participants
|
64.75 Years
STANDARD_DEVIATION 10.68 • n=4 Participants
|
65.25 Years
STANDARD_DEVIATION 10.39 • n=7 Participants
|
66.64 Years
STANDARD_DEVIATION 7.15 • n=7 Participants
|
63.04 Years
STANDARD_DEVIATION 8.12 • n=3 Participants
|
62.50 Years
STANDARD_DEVIATION 12.57 • n=4 Participants
|
56.63 Years
STANDARD_DEVIATION 9.32 • n=2 Participants
|
54.33 Years
STANDARD_DEVIATION 14.60 • n=102 Participants
|
65.67 Years
STANDARD_DEVIATION 10.65 • n=5 Participants
|
63.50 Years
STANDARD_DEVIATION 10.89 • n=5 Participants
|
66.67 Years
STANDARD_DEVIATION 10.29 • n=15 Participants
|
61.58 Years
STANDARD_DEVIATION 6.56 • n=138 Participants
|
59.08 Years
STANDARD_DEVIATION 11.29 • n=4 Participants
|
61.36 Years
STANDARD_DEVIATION 10.54 • n=4 Participants
|
58.50 Years
STANDARD_DEVIATION 16.29 • n=4 Participants
|
66.14 Years
STANDARD_DEVIATION 5.27 • n=4 Participants
|
60.00 Years
STANDARD_DEVIATION 21.63 • n=4 Participants
|
62.11 Years
STANDARD_DEVIATION 11.45 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
21 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
9 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
7 Participants
|
5 Participants
n=19 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=3 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=2 Participants
|
1 Participants
n=102 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=15 Participants
|
3 Participants
n=138 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
149 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
31 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
12 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
4 Participants
|
7 Participants
n=19 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=7 Participants
|
22 Participants
n=3 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=2 Participants
|
5 Participants
n=102 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=15 Participants
|
9 Participants
n=138 Participants
|
9 Participants
n=4 Participants
|
10 Participants
n=4 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=4 Participants
|
259 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=138 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
32 Participants
n=31 Participants
|
19 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
19 Participants
n=6 Participants
|
11 Participants
n=114 Participants
|
11 Participants
|
11 Participants
n=19 Participants
|
11 Participants
n=4 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=3 Participants
|
9 Participants
n=4 Participants
|
6 Participants
n=2 Participants
|
6 Participants
n=102 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=15 Participants
|
12 Participants
n=138 Participants
|
12 Participants
n=4 Participants
|
11 Participants
n=4 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=4 Participants
|
376 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=138 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=138 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
2 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=102 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=15 Participants
|
4 Participants
n=138 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
46 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=138 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
1 Participants
|
2 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=102 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=138 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
30 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
16 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
8 Participants
|
9 Participants
n=19 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=3 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=2 Participants
|
4 Participants
n=102 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=15 Participants
|
7 Participants
n=138 Participants
|
11 Participants
n=4 Participants
|
11 Participants
n=4 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
305 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=138 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=138 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
25 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Cycle 2 (up to 8 weeks)Population: The analysis population included all participants enrolled in Phase 1b who were in the safety analysis set (all participants who received at least one dose of study drug) and received at least 75% of the prescribed doses unless due to treatment-related toxicity or either experienced DLT during the first 2 cycles (1 cycle = 4 weeks) or completed observation period for the first 2 cycles of treatment. Here, "N''=number of participants evaluable for this outcome measure.
Severity of AEs graded as per CTCAE v4.03. Phase 1b lead-in, AEs occurring during DLT observation period, that attributable to one or more study drug in combination was classified as DLT: Hematologic: Grade (G)4 neutropenia lasting \>7 day; Febrile neutropenia; Neutropenic infection; G \>=3 thrombocytopenia with bleeding; G4 thrombocytopenia; G4 anemia. Non-Hematologic (Non-Laboratory): Any G3 toxicity, except following: Transient (24 H) G3 fatigue, local reaction, or headache that resolved to G1; G3-4 nausea/vomiting controlled by medical therapy within 72H; G3 hypertension controlled by medical therapy; G3 diarrhea improved to G \<=2 within 72H after medical therapy; G3 skin toxicity resolved to G \<=1 in \<7 days after medical management; G \>=3 amylase or lipase abnormality not associated with pancreatitis;G3 endocrinopathies controlled with medical therapy; Tumor flare phenomenon.G4 or G3 CRS lasting \>24 H despite treatment.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=29 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=28 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=29 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b Lead-in: Number of Participants With First 2 Cycles Dose Limiting Toxicity (DLT) for Combination A
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Cycle 2 (up to 8 weeks)Population: The analysis population included all participants enrolled in Phase 1b who were in the safety analysis set (all participants who received at least one dose of study drug) and received at least 75% of the prescribed doses unless due to treatment-related toxicity or either experienced DLT during the first 2 cycles (1 cycle = 4 weeks) or completed observation period for the first 2 cycles of treatment. Here, "N''=number of participants evaluable for this outcome measure.
Severity of AEs graded as per CTCAE v4.03. Phase 1b lead-in, AEs occurring during DLT observation period, that attributable to one or more study drug in combination was classified as DLT: Hematologic: Grade (G)4 neutropenia lasting \>7 day; Febrile neutropenia; Neutropenic infection; G \>=3 thrombocytopenia with bleeding; G4 thrombocytopenia; G4 anemia. Non-Hematologic (Non-Laboratory): Any G3 toxicity, except following: Transient (24 H) G3 fatigue, local reaction, or headache that resolved to G1; G3-4 nausea/vomiting controlled by medical therapy within 72H; G3 hypertension controlled by medical therapy; G3 diarrhea improved to G \<=2 within 72H after medical therapy; G3 skin toxicity resolved to G \<=1 in \<7 days after medical management; G \>=3 amylase or lipase abnormality not associated with pancreatitis;G3 endocrinopathies controlled with medical therapy; Tumor flare phenomenon.G4 or G3 CRS lasting \>24 H despite treatment.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=12 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=8 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b Lead-in: Number of Participants With First 2 Cycles DLT for Combination B
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Cycle 2 (up to 8 weeks)Population: The analysis population included all participants enrolled in Phase 1b who were in the safety analysis set (all participants who received at least one dose of study drug) and received at least 75% of the prescribed doses unless due to treatment-related toxicity or either experienced DLT during the first 2 cycles (1 cycle = 4 weeks) or completed observation period for the first 2 cycles of treatment. Here, "N''=number of participants evaluable for this outcome measure.
Severity of AEs graded as per CTCAE v4.03. Phase 1b lead-in, AEs occurring during DLT observation period, that attributable to one or more study drug in combination was classified as DLT: Hematologic: Grade (G)4 neutropenia lasting \>7 day; Febrile neutropenia; Neutropenic infection; G \>=3 thrombocytopenia with bleeding; G4 thrombocytopenia; G4 anemia. Non-Hematologic (Non-Laboratory): Any G3 toxicity, except following: Transient (24 H) G3 fatigue, local reaction, or headache that resolved to G1; G3-4 nausea/vomiting controlled by medical therapy within 72H; G3 hypertension controlled by medical therapy; G3 diarrhea improved to G \<=2 within 72H after medical therapy; G3 skin toxicity resolved to G \<=1 in \<7 days after medical management; G \>=3 amylase or lipase abnormality not associated with pancreatitis;G3 endocrinopathies controlled with medical therapy; Tumor flare phenomenon.G4 or G3 CRS lasting \>24 H despite treatment.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=10 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=8 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=6 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b Lead-in: Number of Participants With First 2 Cycles DLT for Combination C
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Cycle 2 (up to 8 weeks)Population: The analysis population included all participants enrolled in Phase 1b who were in the safety analysis set (all participants who received at least one dose of study drug) and received at least 75% of the prescribed doses unless due to treatment-related toxicity or either experienced DLT during the first 2 cycles (1 cycle = 4 weeks) or completed observation period for the first 2 cycles of treatment. Here, "N''=number of participants evaluable for this outcome measure.
Severity of AEs graded as per CTCAE v4.03. Phase 1b lead-in, AEs occurring during DLT observation period, that attributable to one or more study drug in combination was classified as DLT: Hematologic: Grade (G)4 neutropenia lasting \>7 day; Febrile neutropenia; Neutropenic infection; G \>=3 thrombocytopenia with bleeding; G4 thrombocytopenia; G4 anemia. Non-Hematologic (Non-Laboratory): Any G3 toxicity, except following: Transient (24 H) G3 fatigue, local reaction, or headache that resolved to G1; G3-4 nausea/vomiting controlled by medical therapy within 72H; G3 hypertension controlled by medical therapy; G3 diarrhea improved to G \<=2 within 72H after medical therapy; G3 skin toxicity resolved to G \<=1 in \<7 days after medical management; G \>=3 amylase or lipase abnormality not associated with pancreatitis;G3 endocrinopathies controlled with medical therapy; Tumor flare phenomenon.G4 or G3 CRS lasting \>24 H despite treatment.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=11 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=10 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=11 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=9 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=11 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=8 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b Lead-in: Number of Participants With First 2 Cycles DLT for Combination D
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to first Cycle (up to 4 weeks)Population: The analysis population included all participants enrolled in Phase 1b who were in the safety analysis set (all participants who received at least one dose of study drug) and received at least 75% of the prescribed doses unless due to treatment-related toxicity or either experienced DLT during the first cycle (1 cycle = 4 weeks) or completed observation period for the first cycle of treatment. Here, "N''=number of participants evaluable for this outcome measure.
Severity of AEs graded as per CTCAE v4.03. Phase 1b lead-in, AEs occurring during DLT observation period, that attributable to one or more study drug in combination was classified as DLT: Hematologic: Grade (G)4 neutropenia lasting \>7 day; Febrile neutropenia; Neutropenic infection; G \>=3 thrombocytopenia with bleeding; G4 thrombocytopenia; G4 anemia. Non-Hematologic (Non-Laboratory): Any G3 toxicity, except following: Transient (24 H) G3 fatigue, local reaction, or headache that resolved to G1; G3-4 nausea/vomiting controlled by medical therapy within 72H; G3 hypertension controlled by medical therapy; G3 diarrhea improved to G \<=2 within 72H after medical therapy; G3 skin toxicity resolved to G \<=1 in \<7 days after medical management; G \>=3 amylase or lipase abnormality not associated with pancreatitis;G3 endocrinopathies controlled with medical therapy; Tumor flare phenomenon.G4 or G3 CRS lasting \>24 H despite treatment.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=6 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=6 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=6 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b Lead-in: Number of Participants With First Cycle DLT for Combination F
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 53 months approximately)Population: The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one treatment the participant was classified according to the first treatment received.
OR: complete response(CR) or partial response(PR)determined by investigator according to RECIST v1.1 from date of first dose of study treatment until date of first documentation of progressive disease(PD),confirmed by repeat assessments performed no less than 4 weeks after first response. CR: disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, target and non-target must have short axis measures less than (\<)10 millimeter(mm). PR: \>=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD: \>=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm, appearance of one or more new lesions was considered PD.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=28 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=35 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=21 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=10 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=21 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=11 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=11 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Percentage of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment for Combination A
|
10.7 Percentage of participants
Interval 2.3 to 28.2
|
8.6 Percentage of participants
Interval 1.8 to 23.1
|
14.3 Percentage of participants
Interval 3.0 to 36.3
|
10.0 Percentage of participants
Interval 0.3 to 44.5
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
54.5 Percentage of participants
Interval 23.4 to 83.3
|
18.2 Percentage of participants
Interval 2.3 to 51.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of the treatment until disease progression or death due to any cause, whichever occurred first (approximately 26 months)Population: The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one treatment the participant was classified according to the first treatment received.
OR: CR or PR determined by investigator according to RECIST v1.1 from date of first dose of study treatment until date of first documentation of PD, confirmed by repeat assessments performed no less than 4 weeks after first response. CR: disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, target and non-target must have short axis measures \<10 mm. PR: \>=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD: \>=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5 mm, appearance of one or more new lesions was considered PD.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=14 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=25 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Percentage of Participants With Confirmed OR as Per RECIST v 1.1 by Investigator Assessment for Combination B
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
8.0 Percentage of participants
Interval 1.0 to 26.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 6.5 years)Population: The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one study treatment, the participant were classified according to the first treatment received.
TEAEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Per National Cancer Institute (NCI) CTCAE v4.03: Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment; Grade 4 (Life-threatening) events caused participant to be in imminent danger of death; Grade 5 (Death) events=death related to an AE. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in participant hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=29 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=27 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=29 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=28 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=35 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=21 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=10 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
n=21 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
n=11 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=11 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination A
Serious TEAEs
|
11 Participants
|
12 Participants
|
13 Participants
|
9 Participants
|
16 Participants
|
4 Participants
|
4 Participants
|
8 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination A
Treatment related TEAEs
|
22 Participants
|
22 Participants
|
25 Participants
|
23 Participants
|
26 Participants
|
15 Participants
|
8 Participants
|
19 Participants
|
10 Participants
|
9 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination A
TEAEs
|
29 Participants
|
27 Participants
|
29 Participants
|
28 Participants
|
35 Participants
|
20 Participants
|
10 Participants
|
21 Participants
|
11 Participants
|
11 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination A
Grade >=3 TEAEs
|
15 Participants
|
13 Participants
|
18 Participants
|
13 Participants
|
19 Participants
|
9 Participants
|
7 Participants
|
12 Participants
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 3.5 years)Population: The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one study treatment, the participant were classified according to the first treatment received.
TEAEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period. Treatment-related AEs was any untoward medical occurrence attributed to study drug in a participant who received study drug. Per NCI CTCAE v4.03: Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment; Grade 4 (Life-threatening) events caused participant to be in imminent danger of death; Grade 5 (Death) events=death related to an AE. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in participant hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=12 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=8 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=14 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=25 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination B
TEAEs
|
12 Participants
|
12 Participants
|
8 Participants
|
14 Participants
|
25 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination B
Grade >=3 TEAEs
|
4 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination B
Serious TEAEs
|
3 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination B
Treatment related TEAEs
|
7 Participants
|
7 Participants
|
7 Participants
|
12 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 1.8 years)Population: The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one study treatment, the participant were classified according to the first treatment received.
TEAEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period. Treatment-related AEs was any untoward medical occurrence attributed to study drug in a participant who received study drug. Per NCI CTCAE v4.03: Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment; Grade 4 (Life-threatening) events caused participant to be in imminent danger of death; Grade 5 (Death) events=death related to an AE. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in participant hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=10 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=8 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=6 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination C
TEAEs
|
9 Participants
|
8 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination C
Grade >=3 TEAEs
|
5 Participants
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination C
Treatment related TEAEs
|
7 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination C
Serious TEAEs
|
4 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 4.3 years)Population: The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one study treatment, the participant were classified according to the first treatment received.
TEAEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period. Treatment-related AEs was any untoward medical occurrence attributed to study drug in a participant who received study drug. Per NCI CTCAE v4.03: Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment; Grade 4 (Life-threatening) events caused participant to be in imminent danger of death; Grade 5 (Death) events=death related to an AE. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in participant hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=12 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=11 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination D
Grade >=3 TEAEs
|
5 Participants
|
8 Participants
|
5 Participants
|
7 Participants
|
6 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination D
TEAEs
|
12 Participants
|
12 Participants
|
12 Participants
|
12 Participants
|
12 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination D
Serious TEAEs
|
2 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination D
Treatment related TEAEs
|
7 Participants
|
11 Participants
|
9 Participants
|
10 Participants
|
10 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 3 years)Population: The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one study treatment, the participant were classified according to the first treatment received.
TEAEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period. Treatment-related AEs was any untoward medical occurrence attributed to study drug in a participant who received study drug. Per NCI CTCAE v4.03: Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment; Grade 4 (Life-threatening) events caused participant to be in imminent danger of death; Grade 5 (Death) events=death related to an AE. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in participant hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=6 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=7 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=7 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination F
TEAEs
|
6 Participants
|
7 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination F
Grade >=3 TEAEs
|
4 Participants
|
5 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination F
Serious TEAEs
|
2 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination F
Treatment related TEAEs
|
6 Participants
|
6 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to end of treatment/withdrawal (maximum of 6.5 years)Population: All participants who received at least one dose of study drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Participants were classified according to study treatment actually received. If participant received more than one study treatment, participant was classified according to first treatment received. Here, "N''=number of participants evaluable for this outcome measure.
The laboratory results were graded according to the NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Number of participants with new abnormal or worsening hematology laboratory test is presented." Participants with any grade \>=3 is presented for following parameters: Anemia, lymphocyte count decreased, Platelet count decreased, neutrophil count decreased, and white blood cell decreased. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=28 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=27 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=29 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=28 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=34 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=21 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=10 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
n=21 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
n=11 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=11 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3: Combination A
Participants with any grade >= 3 Anemia
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3: Combination A
Participants with any grade >=3 Lymphocyte Count Decreased
|
7 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3: Combination A
Participants with any grade >= 3 Neutrophil Count Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3: Combination A
Participants with any grade >= 3 Platelet Count Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3: Combination A
Participants with any grade >= 3 White Blood Cell Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to end of treatment/withdrawal (maximum of 3.5 years)Population: All participants who received at least one dose of study drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Participants were classified according to study treatment actually received. If participant received more than one study treatment, participant was classified according to first treatment received. Here, "N''=number of participants evaluable for this outcome measure.
The laboratory results were graded according to the NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Number of participants with new abnormal or worsening hematology laboratory test is presented." Participants with any grade \>=3 is presented for following parameters: Anemia, lymphocyte count decreased, Platelet count decreased, neutrophil count decreased, and white blood cell decreased. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=12 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=8 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=14 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=24 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination B
Participants with any grade >= 3 Anemia
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination B
Participants with any grade >=3 Lymphocyte Count Decreased
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination B
Participants with any grade >= 3 Platelet Count Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination B
Participants with any grade >= 3 Neutrophil Count Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination B
Participants with any grade >= 3 White Blood Cell Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to end of treatment/withdrawal (maximum of 1.8 years)Population: All participants who received at least one dose of study drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Participants were classified according to study treatment actually received. If participant received more than one study treatment, participant was classified according to first treatment received. Here, "N''=number of participants evaluable for this outcome measure.
The laboratory results were graded according to the NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Number of participants with new abnormal or worsening hematology laboratory test is presented." Participants with any grade \>=3 is presented for following parameters: Anemia, lymphocyte count decreased, Platelet count decreased, neutrophil count decreased, and white blood cell decreased. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=10 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=8 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=6 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination C
Participants with any grade >= 3 Neutrophil Count Decreased
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination C
Participants with any grade >= 3 Anemia
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination C
Participants with any grade >=3 Lymphocyte Count Decreased
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination C
Participants with any grade >= 3 Platelet Count Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination C
Participants with any grade >= 3 White Blood Cell Decreased
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to end of treatment/withdrawal (maximum of 4.3 years)Population: All participants who received at least one dose of study drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Participants were classified according to study treatment actually received. If participant received more than one study treatment, participant was classified according to first treatment received. Here, "N''=number of participants evaluable for this outcome measure.
The laboratory results were graded according to the NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Number of participants with new abnormal or worsening hematology laboratory test is presented." Participants with any grade \>=3 is presented for following parameters: Anemia, lymphocyte count decreased, Platelet count decreased, neutrophil count decreased, and white blood cell decreased. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=11 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=11 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=11 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination D
Participants with any grade >=3 Lymphocyte Count Decreased
|
3 Participants
|
6 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination D
Participants with any grade >= 3 Anemia
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination D
Participants with any grade >= 3 Neutrophil Count Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination D
Participants with any grade >= 3 Platelet Count Decreased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination D
Participants with any grade >= 3 White Blood Cell Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to end of treatment/withdrawal (maximum of 3 years)Population: All participants who received at least one dose of study drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Participants were classified according to study treatment actually received. If participant received more than one study treatment, participant was classified according to first treatment received. Here, "N''=number of participants evaluable for this outcome measure.
The laboratory results were graded according to the NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Number of participants with new abnormal or worsening hematology laboratory test is presented." Participants with any grade \>=3 is presented for following parameters: Anemia, lymphocyte count decreased, Platelet count decreased, neutrophil count decreased, and white blood cell decreased. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=5 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=7 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=7 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination F
Participants with any grade >= 3 Anemia
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination F
Participants with any grade >=3 Lymphocyte Count Decreased
|
1 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination F
Participants with any grade >= 3 Neutrophil Count Decreased
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination F
Participants with any grade >= 3 Platelet Count Decreased
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination F
Participants with any grade >= 3 White Blood Cell Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to end of treatment/withdrawal (maximum of 6.5 years)Population: All participants who received at least one dose of study drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Participants were classified according to study treatment actually received. If participant received more than one study treatment, participant was classified according to first treatment received. Here, "N''=number of participants evaluable for this outcome measure, where n=number of participants evaluable for specified rows.
The laboratory results were graded according to the NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Number of participants with new abnormal or worsening chemistry laboratory test is presented." Participants with any grade \>=3 is presented for following parameters: Alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hyperglycemia, lipase increased and serum amylase increased. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=28 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=27 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=29 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=28 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=34 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=21 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=10 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
n=21 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
n=11 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=11 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination A
Participants with any grade >= 3 Aspartate Aminotransferase Increased
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination A
Participants with any grade >= 3 Blood Bilirubin Increased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination A
Participants with any grade >= 3 Creatinine Increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination A
Participants with any grade >= 3 Hyperglycemia
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination A
Participants with any grade >= 3 Lipase Increased
|
2 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination A
Participants with any grade >= 3 Serum Amylase Increased
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination A
Participants with any grade >= 3 Alanine Aminotransferase Increased
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination A
Participants with any grade >= 3 Alkaline Phosphatase Increased
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to end of treatment/withdrawal (maximum of 3.5 years)Population: All participants who received at least one dose of study drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Participants were classified according to study treatment actually received. If participant received more than one study treatment, participant was classified according to first treatment received. Here, "N''=number of participants evaluable for this outcome measure.
The laboratory results were graded according to the NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Number of participants with new abnormal or worsening chemistry laboratory test is presented." Participants with any grade \>=3 is presented for following parameters: Alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hyperglycemia, lipase increased and serum amylase increased. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=12 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=8 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=14 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=24 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination B
Participants with any grade >= 3 Alanine Aminotransferase Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination B
Participants with any grade >= 3 Hyperglycemia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination B
Participants with any grade >= 3 Lipase Increased
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination B
Participants with any grade >= 3 Aspartate Aminotransferase Increased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination B
Participants with any grade >= 3 Serum Amylase Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination B
Participants with any grade >= 3 Creatinine Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination B
Participants with any grade >= 3 Alkaline Phosphatase Increased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination B
Participants with any grade >= 3 Blood Bilirubin Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to end of treatment/withdrawal (maximum of 1.8 years)Population: All participants who received at least one dose of study drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Participants were classified according to study treatment actually received. If participant received more than one study treatment, participant was classified according to first treatment received. Here, "N''=number of participants evaluable for this outcome measure.
The laboratory results were graded according to the NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Number of participants with new abnormal or worsening chemistry laboratory test is presented." Participants with any grade \>=3 is presented for following parameters: Alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hyperglycemia, lipase increased and serum amylase increased. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=10 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=8 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=6 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination C
Participants with any grade >= 3 Alanine Aminotransferase Increased
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination C
Participants with any grade >= 3 Alkaline Phosphatase Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination C
Participants with any grade >= 3 Aspartate Aminotransferase Increased
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination C
Participants with any grade >= 3 Blood Bilirubin Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination C
Participants with any grade >= 3 Creatinine Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination C
Participants with any grade >= 3 Hyperglycemia
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination C
Participants with any grade >= 3 Lipase Increased
|
1 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination C
Participants with any grade >= 3 Serum Amylase Increased
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to end of treatment/withdrawal (maximum of 4.3 years)Population: All participants who received at least one dose of study drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Participants were classified according to study treatment actually received. If participant received more than one study treatment, participant was classified according to first treatment received. Here, "N''=number of participants evaluable for this outcome measure.
The laboratory results were graded according to the NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Number of participants with new abnormal or worsening chemistry laboratory test is presented." Participants with any grade \>=3 is presented for following parameters: Alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hyperglycemia, lipase increased and serum amylase increased. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=11 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=11 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=11 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination D
Participants with any grade >= 3 Alkaline Phosphatase Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination D
Participants with any grade >= 3 Aspartate Aminotransferase Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination D
Participants with any grade >= 3 Creatinine Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination D
Participants with any grade >= 3 Hyperglycemia
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination D
Participants with any grade >= 3 Lipase Increased
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination D
Participants with any grade >= 3 Serum Amylase Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination D
Participants with any grade >= 3 Alanine Aminotransferase Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination D
Participants with any grade >= 3 Blood Bilirubin Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to end of treatment/withdrawal (maximum of 3 years)Population: All participants who received at least one dose of study drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Participants were classified according to study treatment actually received. If participant received more than one study treatment, participant was classified according to first treatment received. Here, "N''=number of participants evaluable for this outcome measure.
The laboratory results were graded according to the NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Number of participants with new abnormal or worsening chemistry laboratory test is presented." Participants with any grade \>=3 is presented for following parameters: Alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hyperglycemia, lipase increased and serum amylase increased. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=5 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=7 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=7 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination F
Participants with any grade >= 3 Alanine Aminotransferase Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination F
Participants with any grade >= 3 Alkaline Phosphatase Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination F
Participants with any grade >= 3 Aspartate Aminotransferase Increased
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination F
Participants with any grade >= 3 Blood Bilirubin Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination F
Participants with any grade >= 3 Creatinine Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination F
Participants with any grade >= 3 Hyperglycemia
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination F
Participants with any grade >= 3 Lipase Increased
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination F
Participants with any grade >= 3 Serum Amylase Increased
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1-hour post-dose (at end of infusion) on Day 1,15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Day 1 of Cycle 2, 4, 6, 10. For ''Phase 2 1L NSCLC: Utomilumab then Utomilumab + Avelumab'' reporting group: Day 1 of Cycle 2, 4, 6, 10Population: All participants who received at least one dose of study drug and who had at least one of the PK concentrations for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points. For ''Phase 2 1L NSCLC: Utomilumab then Utomilumab + Avelumab'' reporting group PK sampling started from Cycle 2 Day 1.
Cmax is maximum observed plasma concentration.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=28 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=27 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=29 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=26 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=29 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=21 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=9 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
n=20 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
n=7 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=10 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination A
Cycle 6/Day1-1 Hour/EOI
|
248.4 Nanogram per milliliter
Geometric Coefficient of Variation 32
|
211.1 Nanogram per milliliter
Geometric Coefficient of Variation 20
|
193.2 Nanogram per milliliter
Geometric Coefficient of Variation 121
|
512.8 Nanogram per milliliter
Geometric Coefficient of Variation 126
|
217.1 Nanogram per milliliter
Geometric Coefficient of Variation 28
|
305.9 Nanogram per milliliter
Geometric Coefficient of Variation 18
|
332.9 Nanogram per milliliter
Geometric Coefficient of Variation 3
|
275.2 Nanogram per milliliter
Geometric Coefficient of Variation 42
|
208.3 Nanogram per milliliter
Geometric Coefficient of Variation 17
|
218.3 Nanogram per milliliter
Geometric Coefficient of Variation 11
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination A
Cycle 10/Day1-1 Hour/EOI
|
230.0 Nanogram per milliliter
Geometric Coefficient of Variation 48
|
180.5 Nanogram per milliliter
Geometric Coefficient of Variation 39
|
328.1 Nanogram per milliliter
Geometric Coefficient of Variation 14
|
248.4 Nanogram per milliliter
Geometric Coefficient of Variation 14
|
228.1 Nanogram per milliliter
Geometric Coefficient of Variation 20
|
187.2 Nanogram per milliliter
Geometric Coefficient of Variation 73
|
335.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
|
102.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
|
251.2 Nanogram per milliliter
Geometric Coefficient of Variation 14
|
89.72 Nanogram per milliliter
Geometric Coefficient of Variation 374
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination A
Cycle 1/Day1-1 Hour/End Of Infusion (EOI)
|
232.6 Nanogram per milliliter
Geometric Coefficient of Variation 39
|
219.0 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
231.2 Nanogram per milliliter
Geometric Coefficient of Variation 37
|
262.0 Nanogram per milliliter
Geometric Coefficient of Variation 56
|
209.0 Nanogram per milliliter
Geometric Coefficient of Variation 31
|
215.5 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
284.2 Nanogram per milliliter
Geometric Coefficient of Variation 16
|
218.6 Nanogram per milliliter
Geometric Coefficient of Variation 29
|
—
|
194.4 Nanogram per milliliter
Geometric Coefficient of Variation 27
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination A
Cycle 1/Day8-168 Hour
|
63.60 Nanogram per milliliter
Geometric Coefficient of Variation 52
|
59.86 Nanogram per milliliter
Geometric Coefficient of Variation 65
|
61.49 Nanogram per milliliter
Geometric Coefficient of Variation 84
|
73.57 Nanogram per milliliter
Geometric Coefficient of Variation 78
|
69.14 Nanogram per milliliter
Geometric Coefficient of Variation 43
|
60.03 Nanogram per milliliter
Geometric Coefficient of Variation 33
|
51.85 Nanogram per milliliter
Geometric Coefficient of Variation 36
|
45.69 Nanogram per milliliter
Geometric Coefficient of Variation 25
|
—
|
34.46 Nanogram per milliliter
Geometric Coefficient of Variation 45
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination A
Cycle 1/Day15-1 Hour/EOI
|
212.1 Nanogram per milliliter
Geometric Coefficient of Variation 84
|
226.1 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
253.6 Nanogram per milliliter
Geometric Coefficient of Variation 31
|
279.4 Nanogram per milliliter
Geometric Coefficient of Variation 33
|
238.9 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
241.9 Nanogram per milliliter
Geometric Coefficient of Variation 29
|
324.6 Nanogram per milliliter
Geometric Coefficient of Variation 27
|
221.2 Nanogram per milliliter
Geometric Coefficient of Variation 23
|
—
|
193.7 Nanogram per milliliter
Geometric Coefficient of Variation 24
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination A
Cycle 2/Day1-1 Hour/EOI
|
276.0 Nanogram per milliliter
Geometric Coefficient of Variation 33
|
229.0 Nanogram per milliliter
Geometric Coefficient of Variation 33
|
267.9 Nanogram per milliliter
Geometric Coefficient of Variation 31
|
255.5 Nanogram per milliliter
Geometric Coefficient of Variation 72
|
223.4 Nanogram per milliliter
Geometric Coefficient of Variation 30
|
292.0 Nanogram per milliliter
Geometric Coefficient of Variation 18
|
302.5 Nanogram per milliliter
Geometric Coefficient of Variation 23
|
222.0 Nanogram per milliliter
Geometric Coefficient of Variation 29
|
200.1 Nanogram per milliliter
Geometric Coefficient of Variation 20
|
203.3 Nanogram per milliliter
Geometric Coefficient of Variation 16
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination A
Cycle 4/Day1-1 Hour/EOI
|
258.4 Nanogram per milliliter
Geometric Coefficient of Variation 18
|
232.8 Nanogram per milliliter
Geometric Coefficient of Variation 20
|
285.6 Nanogram per milliliter
Geometric Coefficient of Variation 16
|
303.1 Nanogram per milliliter
Geometric Coefficient of Variation 79
|
209.5 Nanogram per milliliter
Geometric Coefficient of Variation 22
|
283.0 Nanogram per milliliter
Geometric Coefficient of Variation 27
|
215.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
|
273.5 Nanogram per milliliter
Geometric Coefficient of Variation 18
|
206.9 Nanogram per milliliter
Geometric Coefficient of Variation 13
|
97.46 Nanogram per milliliter
Geometric Coefficient of Variation 237
|
SECONDARY outcome
Timeframe: 1-hour post-infusion (at end of infusion) on Day 1 of Cycle 1,3,5,8,12; Day 8 of Cycle 1 (non-dosing). For ''Phase 2 1L NSCLC: Avelumab then Utomilumab + Avelumab'' reporting group: Day 1 of Cycle 3,5,8,12Population: All participants who received at least one dose of study drug and who had at least one of the PK concentrations for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points. For participants of ''Phase 2 1L NSCLC: Avelumab then Utomilumab + Avelumab'' reporting group PK sampling started from Cycle 3 Day 1.
Cmax is maximum observed plasma concentration.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=28 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=27 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=29 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=28 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=32 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=21 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=10 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
n=20 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
n=10 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=7 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Utomilumab in Combination A
Cycle 1/Day1-1 Hour/EOI
|
106500 Nanogram per milliliter
Geometric Coefficient of Variation 31
|
27250 Nanogram per milliliter
Geometric Coefficient of Variation 30
|
4673 Nanogram per milliliter
Geometric Coefficient of Variation 45
|
23520 Nanogram per milliliter
Geometric Coefficient of Variation 34
|
26960 Nanogram per milliliter
Geometric Coefficient of Variation 24
|
23780 Nanogram per milliliter
Geometric Coefficient of Variation 39
|
20790 Nanogram per milliliter
Geometric Coefficient of Variation 39
|
20570 Nanogram per milliliter
Geometric Coefficient of Variation 28
|
26020 Nanogram per milliliter
Geometric Coefficient of Variation 35
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Utomilumab in Combination A
Cycle 1/Day8-168 Hour
|
15940 Nanogram per milliliter
Geometric Coefficient of Variation 126
|
4584 Nanogram per milliliter
Geometric Coefficient of Variation 93
|
1070 Nanogram per milliliter
Geometric Coefficient of Variation 38
|
5740 Nanogram per milliliter
Geometric Coefficient of Variation 73
|
7344 Nanogram per milliliter
Geometric Coefficient of Variation 60
|
8692 Nanogram per milliliter
Geometric Coefficient of Variation 56
|
5036 Nanogram per milliliter
Geometric Coefficient of Variation 35
|
6671 Nanogram per milliliter
Geometric Coefficient of Variation 41
|
7185 Nanogram per milliliter
Geometric Coefficient of Variation 135
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Utomilumab in Combination A
Cycle 3/Day1-1 Hour/EOI
|
132000 Nanogram per milliliter
Geometric Coefficient of Variation 19
|
26250 Nanogram per milliliter
Geometric Coefficient of Variation 19
|
6446 Nanogram per milliliter
Geometric Coefficient of Variation 58
|
26210 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
28880 Nanogram per milliliter
Geometric Coefficient of Variation 31
|
35950 Nanogram per milliliter
Geometric Coefficient of Variation 21
|
15170 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
20190 Nanogram per milliliter
Geometric Coefficient of Variation 66
|
27710 Nanogram per milliliter
Geometric Coefficient of Variation 35
|
26710 Nanogram per milliliter
Geometric Coefficient of Variation 21
|
|
Maximum Observed Plasma Concentration (Cmax) of Utomilumab in Combination A
Cycle 5/Day1-1 Hour/EOI
|
134800 Nanogram per milliliter
Geometric Coefficient of Variation 29
|
26470 Nanogram per milliliter
Geometric Coefficient of Variation 70
|
5800 Nanogram per milliliter
Geometric Coefficient of Variation 48
|
32630 Nanogram per milliliter
Geometric Coefficient of Variation 51
|
28370 Nanogram per milliliter
Geometric Coefficient of Variation 25
|
28000 Nanogram per milliliter
Geometric Coefficient of Variation 36
|
11270 Nanogram per milliliter
Geometric Coefficient of Variation 98
|
19440 Nanogram per milliliter
Geometric Coefficient of Variation 48
|
25650 Nanogram per milliliter
Geometric Coefficient of Variation 30
|
15410 Nanogram per milliliter
Geometric Coefficient of Variation 141
|
|
Maximum Observed Plasma Concentration (Cmax) of Utomilumab in Combination A
Cycle 8/Day1-1 Hour/EOI
|
121800 Nanogram per milliliter
Geometric Coefficient of Variation 28
|
13340 Nanogram per milliliter
Geometric Coefficient of Variation 951
|
6067 Nanogram per milliliter
Geometric Coefficient of Variation 20
|
38930 Nanogram per milliliter
Geometric Coefficient of Variation 85
|
19870 Nanogram per milliliter
Geometric Coefficient of Variation 92
|
20710 Nanogram per milliliter
Geometric Coefficient of Variation 38
|
20710 Nanogram per milliliter
Geometric Coefficient of Variation 22
|
16750 Nanogram per milliliter
Geometric Coefficient of Variation 34
|
21680 Nanogram per milliliter
Geometric Coefficient of Variation 22
|
18080 Nanogram per milliliter
Geometric Coefficient of Variation 89
|
|
Maximum Observed Plasma Concentration (Cmax) of Utomilumab in Combination A
Cycle 12/Day1-1 Hour/EOI
|
124800 Nanogram per milliliter
Geometric Coefficient of Variation 30
|
19800 Nanogram per milliliter
Geometric Coefficient of Variation 62
|
6892 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
44690 Nanogram per milliliter
Geometric Coefficient of Variation 225
|
20460 Nanogram per milliliter
Geometric Coefficient of Variation 8
|
27030 Nanogram per milliliter
Geometric Coefficient of Variation 28
|
—
|
12900 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
|
20730 Nanogram per milliliter
Geometric Coefficient of Variation 33
|
24060 Nanogram per milliliter
Geometric Coefficient of Variation 1
|
SECONDARY outcome
Timeframe: 1-hour post-dose on Day 1,15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Day 1 of Cycle 2, 4, 6 and Cycle 10Population: Pharmacokinetic (PK) analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK concentrations of interest for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points.
Cmax is maximum observed plasma concentration.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=12 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=8 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=13 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=23 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PF-04518600 in Combination B
Avelumab Cycle 1/Day1-1 Hour/EOI
|
220.6 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
257.6 Nanogram per milliliter
Geometric Coefficient of Variation 65
|
213.7 Nanogram per milliliter
Geometric Coefficient of Variation 30
|
219.8 Nanogram per milliliter
Geometric Coefficient of Variation 22
|
178.4 Nanogram per milliliter
Geometric Coefficient of Variation 31
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PF-04518600 in Combination B
Avelumab Cycle 1/Day8-168 Hour
|
54.00 Nanogram per milliliter
Geometric Coefficient of Variation 51
|
42.66 Nanogram per milliliter
Geometric Coefficient of Variation 50
|
49.85 Nanogram per milliliter
Geometric Coefficient of Variation 45
|
50.86 Nanogram per milliliter
Geometric Coefficient of Variation 35
|
47.68 Nanogram per milliliter
Geometric Coefficient of Variation 33
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PF-04518600 in Combination B
Avelumab Cycle 1/Day15-1 Hour/EOI
|
241.9 Nanogram per milliliter
Geometric Coefficient of Variation 23
|
240.3 Nanogram per milliliter
Geometric Coefficient of Variation 17
|
228.7 Nanogram per milliliter
Geometric Coefficient of Variation 33
|
235.5 Nanogram per milliliter
Geometric Coefficient of Variation 29
|
180.3 Nanogram per milliliter
Geometric Coefficient of Variation 68
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PF-04518600 in Combination B
Avelumab Cycle 2/Day1-1 Hour/EOI
|
242.8 Nanogram per milliliter
Geometric Coefficient of Variation 22
|
256.2 Nanogram per milliliter
Geometric Coefficient of Variation 18
|
277.1 Nanogram per milliliter
Geometric Coefficient of Variation 27
|
249.1 Nanogram per milliliter
Geometric Coefficient of Variation 22
|
188.4 Nanogram per milliliter
Geometric Coefficient of Variation 22
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PF-04518600 in Combination B
Avelumab Cycle 4/Day1-1 Hour/EOI
|
223.9 Nanogram per milliliter
Geometric Coefficient of Variation 19
|
204.1 Nanogram per milliliter
Geometric Coefficient of Variation 44
|
254.4 Nanogram per milliliter
Geometric Coefficient of Variation 10
|
184.9 Nanogram per milliliter
Geometric Coefficient of Variation 31
|
205.6 Nanogram per milliliter
Geometric Coefficient of Variation 21
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PF-04518600 in Combination B
Avelumab Cycle 6/Day1-1 Hour/EOI
|
—
|
143.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
|
—
|
280.6 Nanogram per milliliter
Geometric Coefficient of Variation 18
|
137.0 Nanogram per milliliter
Geometric Coefficient of Variation 110
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PF-04518600 in Combination B
Avelumab Cycle 10/Day1-1 Hour/EOI
|
—
|
—
|
—
|
231.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
|
197.2 Nanogram per milliliter
Geometric Coefficient of Variation 13
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PF-04518600 in Combination B
PF- 04518600 Cycle 1/Day1-1 Hour/EOI
|
6413 Nanogram per milliliter
Geometric Coefficient of Variation 21
|
21560 Nanogram per milliliter
Geometric Coefficient of Variation 25
|
74090 Nanogram per milliliter
Geometric Coefficient of Variation 13
|
6919 Nanogram per milliliter
Geometric Coefficient of Variation 28
|
6085 Nanogram per milliliter
Geometric Coefficient of Variation 37
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PF-04518600 in Combination B
PF-04518600 Cycle 1/Day8-168 Hour
|
2669 Nanogram per milliliter
Geometric Coefficient of Variation 51
|
9427 Nanogram per milliliter
Geometric Coefficient of Variation 25
|
31650 Nanogram per milliliter
Geometric Coefficient of Variation 34
|
3131 Nanogram per milliliter
Geometric Coefficient of Variation 32
|
2631 Nanogram per milliliter
Geometric Coefficient of Variation 28
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PF-04518600 in Combination B
PF-04518600 Cycle 1/Day15-1 Hour/EOI
|
5969 Nanogram per milliliter
Geometric Coefficient of Variation 77
|
27460 Nanogram per milliliter
Geometric Coefficient of Variation 24
|
96640 Nanogram per milliliter
Geometric Coefficient of Variation 22
|
6697 Nanogram per milliliter
Geometric Coefficient of Variation 71
|
7173 Nanogram per milliliter
Geometric Coefficient of Variation 35
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PF-04518600 in Combination B
PF-04518600 Cycle 2/Day1-1 Hour/EOI
|
7776 Nanogram per milliliter
Geometric Coefficient of Variation 33
|
31880 Nanogram per milliliter
Geometric Coefficient of Variation 16
|
104100 Nanogram per milliliter
Geometric Coefficient of Variation 56
|
9212 Nanogram per milliliter
Geometric Coefficient of Variation 30
|
7627 Nanogram per milliliter
Geometric Coefficient of Variation 25
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PF-04518600 in Combination B
PF-04518600 Cycle 4/Day1-1 Hour/EOI
|
8792 Nanogram per milliliter
Geometric Coefficient of Variation 43
|
—
|
155000 Nanogram per milliliter
Geometric Coefficient of Variation 20
|
11730 Nanogram per milliliter
Geometric Coefficient of Variation 61
|
10180 Nanogram per milliliter
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PF-04518600 in Combination B
PF-04518600 Cycle 6/Day1-1 Hour/EOI
|
—
|
32000 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
|
—
|
14020 Nanogram per milliliter
Geometric Coefficient of Variation 27
|
9753 Nanogram per milliliter
Geometric Coefficient of Variation 10
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PF-04518600 in Combination B
PF-04518600 Cycle 10/Day1-1 Hour/EOI
|
—
|
—
|
—
|
14060 Nanogram per milliliter
Geometric Coefficient of Variation 16
|
10660 Nanogram per milliliter
Geometric Coefficient of Variation 18
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 hour (i.e. at the end of infusion) post-dose on Day 1,15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Day 1 of Cycle 2, 4, 6 and Cycle 10Population: PK analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK concentrations of interest for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points.
Cmax is maximum observed plasma concentration.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=10 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=7 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=6 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PD 0360324 in Combination C
Avelumab Cycle 1/Day1-1 Hour/EOI
|
217.0 Nanogram per milliliter
Geometric Coefficient of Variation 13
|
209.9 Nanogram per milliliter
Geometric Coefficient of Variation 34
|
247.9 Nanogram per milliliter
Geometric Coefficient of Variation 18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PD 0360324 in Combination C
Avelumab Cycle 1/Day8-168 Hour
|
53.39 Nanogram per milliliter
Geometric Coefficient of Variation 31
|
63.12 Nanogram per milliliter
Geometric Coefficient of Variation 25
|
47.89 Nanogram per milliliter
Geometric Coefficient of Variation 28
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PD 0360324 in Combination C
Avelumab Cycle 1/Day15-1 Hour/EOI
|
233.8 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
277.4 Nanogram per milliliter
Geometric Coefficient of Variation 20
|
263.6 Nanogram per milliliter
Geometric Coefficient of Variation 33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PD 0360324 in Combination C
Avelumab Cycle 2/Day1-1 Hour/EOI
|
253.7 Nanogram per milliliter
Geometric Coefficient of Variation 15
|
295.2 Nanogram per milliliter
Geometric Coefficient of Variation 30
|
254.0 Nanogram per milliliter
Geometric Coefficient of Variation 20
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PD 0360324 in Combination C
Avelumab Cycle 4/Day1-1 Hour/EOI
|
242.0 Nanogram per milliliter
Geometric Coefficient of Variation 24
|
331.1 Nanogram per milliliter
Geometric Coefficient of Variation 29
|
304.8 Nanogram per milliliter
Geometric Coefficient of Variation 44
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PD 0360324 in Combination C
Avelumab Cycle 6/Day1-1 Hour/EOI
|
248.2 Nanogram per milliliter
Geometric Coefficient of Variation 17
|
292.4 Nanogram per milliliter
Geometric Coefficient of Variation 17
|
270.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PD 0360324 in Combination C
Avelumab Cycle 10/Day1-1 Hour/EOI
|
—
|
318.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PD 0360324 in Combination C
PD 0360324 Cycle 1/Day1-30 Minutes (Min)/EOI
|
17570 Nanogram per milliliter
Geometric Coefficient of Variation 22
|
34420 Nanogram per milliliter
Geometric Coefficient of Variation 55
|
38200 Nanogram per milliliter
Geometric Coefficient of Variation 44
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PD 0360324 in Combination C
PD 0360324 Cycle 1/Day8-168 Hour
|
1324 Nanogram per milliliter
Geometric Coefficient of Variation 109
|
8846 Nanogram per milliliter
Geometric Coefficient of Variation 43
|
6598 Nanogram per milliliter
Geometric Coefficient of Variation 47
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PD 0360324 in Combination C
PD 0360324 Cycle 1/Day15-30 min/EOI
|
16620 Nanogram per milliliter
Geometric Coefficient of Variation 27
|
32550 Nanogram per milliliter
Geometric Coefficient of Variation 29
|
46130 Nanogram per milliliter
Geometric Coefficient of Variation 51
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PD 0360324 in Combination C
PD 0360324 Cycle 2/Day1-30 min/EOI
|
17050 Nanogram per milliliter
Geometric Coefficient of Variation 20
|
11690 Nanogram per milliliter
Geometric Coefficient of Variation 1072
|
57420 Nanogram per milliliter
Geometric Coefficient of Variation 16
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PD 0360324 in Combination C
PD 0360324 Cycle 4/Day1-30 min/EOI
|
17700 Nanogram per milliliter
Geometric Coefficient of Variation 2
|
27060 Nanogram per milliliter
Geometric Coefficient of Variation 8
|
43650 Nanogram per milliliter
Geometric Coefficient of Variation 51
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PD 0360324 in Combination C
PD 0360324 Cycle 6/Day1-30 min/EOI
|
15590 Nanogram per milliliter
Geometric Coefficient of Variation 12
|
35140 Nanogram per milliliter
Geometric Coefficient of Variation 8
|
58620 Nanogram per milliliter
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab and PD 0360324 in Combination C
PD 0360324 Cycle 10/Day1-30 min/EOI
|
—
|
33100 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
|
3216 Nanogram per milliliter
Geometric Coefficient of Variation 11668
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 hour post-dose (at end of infusion) on Days 1 and 15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Pre-dose and 1 hour post-dose on Day 1 of Cycle 2, 4, 6, 10Population: PK analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK concentrations of interest for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points.
Cmax is maximum observed plasma concentration.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=11 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=9 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=10 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination D
Cycle 1/Day1-1 Hour/EOI
|
158.3 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
188.2 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
200.8 Nanogram per milliliter
Geometric Coefficient of Variation 22
|
185.1 Nanogram per milliliter
Geometric Coefficient of Variation 38
|
187.4 Nanogram per milliliter
Geometric Coefficient of Variation 18
|
174.2 Nanogram per milliliter
Geometric Coefficient of Variation 32
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination D
Cycle 1/Day8-168 Hour
|
46.74 Nanogram per milliliter
Geometric Coefficient of Variation 46
|
37.71 Nanogram per milliliter
Geometric Coefficient of Variation 20
|
39.14 Nanogram per milliliter
Geometric Coefficient of Variation 24
|
41.96 Nanogram per milliliter
Geometric Coefficient of Variation 24
|
41.32 Nanogram per milliliter
Geometric Coefficient of Variation 24
|
36.07 Nanogram per milliliter
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination D
Cycle 1/Day15-1 Hour/EOI
|
201.8 Nanogram per milliliter
Geometric Coefficient of Variation 20
|
124.1 Nanogram per milliliter
Geometric Coefficient of Variation 136
|
150.8 Nanogram per milliliter
Geometric Coefficient of Variation 91
|
167.3 Nanogram per milliliter
Geometric Coefficient of Variation 17
|
217.2 Nanogram per milliliter
Geometric Coefficient of Variation 20
|
80.14 Nanogram per milliliter
Geometric Coefficient of Variation 1114
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination D
Cycle 2/Day1-1 Hour/EOI
|
200.4 Nanogram per milliliter
Geometric Coefficient of Variation 18
|
190.9 Nanogram per milliliter
Geometric Coefficient of Variation 23
|
149.2 Nanogram per milliliter
Geometric Coefficient of Variation 143
|
142.9 Nanogram per milliliter
Geometric Coefficient of Variation 42
|
228.5 Nanogram per milliliter
Geometric Coefficient of Variation 18
|
175.1 Nanogram per milliliter
Geometric Coefficient of Variation 24
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination D
Cycle 4/Day1-1 Hour/EOI
|
188.9 Nanogram per milliliter
Geometric Coefficient of Variation 30
|
210.0 Nanogram per milliliter
Geometric Coefficient of Variation 23
|
193.9 Nanogram per milliliter
Geometric Coefficient of Variation 29
|
192.8 Nanogram per milliliter
Geometric Coefficient of Variation 6
|
223.2 Nanogram per milliliter
Geometric Coefficient of Variation 16
|
178.7 Nanogram per milliliter
Geometric Coefficient of Variation 25
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination D
Cycle 6/Day1-1 Hour/EOI
|
216.7 Nanogram per milliliter
Geometric Coefficient of Variation 25
|
198.8 Nanogram per milliliter
Geometric Coefficient of Variation 34
|
208.2 Nanogram per milliliter
Geometric Coefficient of Variation 13
|
161.0 Nanogram per milliliter
Geometric Coefficient of Variation 4
|
217.1 Nanogram per milliliter
Geometric Coefficient of Variation 8
|
193.3 Nanogram per milliliter
Geometric Coefficient of Variation 19
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination D
Cycle 10/Day1-1 Hour/EOI
|
203.7 Nanogram per milliliter
Geometric Coefficient of Variation 10
|
196.0 Nanogram per milliliter
Geometric Coefficient of Variation 53
|
194.5 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
182.0 Nanogram per milliliter
Geometric Coefficient of Variation 2
|
268.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
|
229.1 Nanogram per milliliter
Geometric Coefficient of Variation 34
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 hour (at end of infusion) post-dose on Day 1 of Cycles 1, 3, 5, 8 and Cycle 12; Days 8 of Cycle 1 (non-dosing)Population: PK analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK concentrations of interest for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points.
Cmax is maximum observed plasma concentration.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=12 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=11 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=11 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Utomilumab in Combination D
Cycle 1/Day1-1 Hour/EOI
|
3370 Nanogram per milliliter
Geometric Coefficient of Variation 39
|
8935 Nanogram per milliliter
Geometric Coefficient of Variation 67
|
3751 Nanogram per milliliter
Geometric Coefficient of Variation 78
|
4919 Nanogram per milliliter
Geometric Coefficient of Variation 104
|
2155 Nanogram per milliliter
Geometric Coefficient of Variation 79
|
9567 Nanogram per milliliter
Geometric Coefficient of Variation 22
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Utomilumab in Combination D
Cycle 1/Day8-168 Hour
|
1406 Nanogram per milliliter
Geometric Coefficient of Variation 44
|
3066 Nanogram per milliliter
Geometric Coefficient of Variation 22
|
1043 Nanogram per milliliter
Geometric Coefficient of Variation 45
|
2437 Nanogram per milliliter
Geometric Coefficient of Variation 85
|
1318 Nanogram per milliliter
Geometric Coefficient of Variation 34
|
2940 Nanogram per milliliter
Geometric Coefficient of Variation 78
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Utomilumab in Combination D
Cycle 3/Day1-1 Hour/EOI
|
2413 Nanogram per milliliter
Geometric Coefficient of Variation 14
|
11820 Nanogram per milliliter
Geometric Coefficient of Variation 47
|
3953 Nanogram per milliliter
Geometric Coefficient of Variation 51
|
9471 Nanogram per milliliter
Geometric Coefficient of Variation 46
|
2669 Nanogram per milliliter
Geometric Coefficient of Variation 116
|
8877 Nanogram per milliliter
Geometric Coefficient of Variation 12
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Utomilumab in Combination D
Cycle 5/Day1-1 Hour/EOI
|
3477 Nanogram per milliliter
Geometric Coefficient of Variation 51
|
14310 Nanogram per milliliter
Geometric Coefficient of Variation 19
|
2694 Nanogram per milliliter
Geometric Coefficient of Variation 123
|
7500 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
|
2475 Nanogram per milliliter
Geometric Coefficient of Variation 56
|
8029 Nanogram per milliliter
Geometric Coefficient of Variation 21
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Utomilumab in Combination D
Cycle 8/Day1-1 Hour/EOI
|
2596 Nanogram per milliliter
Geometric Coefficient of Variation 8
|
3354 Nanogram per milliliter
Geometric Coefficient of Variation 374
|
3202 Nanogram per milliliter
Geometric Coefficient of Variation 126
|
14790 Nanogram per milliliter
Geometric Coefficient of Variation 24
|
2028 Nanogram per milliliter
Geometric Coefficient of Variation 33
|
5542 Nanogram per milliliter
Geometric Coefficient of Variation 71
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Utomilumab in Combination D
Cycle 12/Day1-1 Hour/EOI
|
2460 Nanogram per milliliter
Geometric Coefficient of Variation 1
|
13400 Nanogram per milliliter
Geometric Coefficient of Variation 9
|
3422 Nanogram per milliliter
Geometric Coefficient of Variation 51
|
13220 Nanogram per milliliter
Geometric Coefficient of Variation 39
|
1120 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 hour post-infusion (at end of infusion) on Day 1 and 15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Day 1 of Cycle 2, 4, 6 and Cycle 10Population: PK analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK concentrations of interest for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points.
Cmax is maximum observed plasma concentration.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=11 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=11 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of PF-04518600 in Combination D
Cycle 1/Day1-1 Hour/End Of Infusion (EOI)
|
1698 Nanogram per milliliter
Geometric Coefficient of Variation 51
|
1714 Nanogram per milliliter
Geometric Coefficient of Variation 24
|
5224 Nanogram per milliliter
Geometric Coefficient of Variation 58
|
4417 Nanogram per milliliter
Geometric Coefficient of Variation 59
|
18250 Nanogram per milliliter
Geometric Coefficient of Variation 30
|
17770 Nanogram per milliliter
Geometric Coefficient of Variation 33
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of PF-04518600 in Combination D
Cycle 1/Day8-168 Hour
|
695.1 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
589.5 Nanogram per milliliter
Geometric Coefficient of Variation 41
|
2379 Nanogram per milliliter
Geometric Coefficient of Variation 30
|
2139 Nanogram per milliliter
Geometric Coefficient of Variation 31
|
9717 Nanogram per milliliter
Geometric Coefficient of Variation 15
|
7700 Nanogram per milliliter
Geometric Coefficient of Variation 35
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of PF-04518600 in Combination D
Cycle 1/Day15-1 Hour/EOI
|
1841 Nanogram per milliliter
Geometric Coefficient of Variation 65
|
1823 Nanogram per milliliter
Geometric Coefficient of Variation 35
|
6595 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
8559 Nanogram per milliliter
Geometric Coefficient of Variation 68
|
24470 Nanogram per milliliter
Geometric Coefficient of Variation 23
|
23330 Nanogram per milliliter
Geometric Coefficient of Variation 22
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of PF-04518600 in Combination D
Cycle 2/Day1-1 Hour/EOI
|
2278 Nanogram per milliliter
Geometric Coefficient of Variation 24
|
1901 Nanogram per milliliter
Geometric Coefficient of Variation 22
|
7497 Nanogram per milliliter
Geometric Coefficient of Variation 39
|
7373 Nanogram per milliliter
Geometric Coefficient of Variation 18
|
25890 Nanogram per milliliter
Geometric Coefficient of Variation 50
|
25180 Nanogram per milliliter
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of PF-04518600 in Combination D
Cycle 4/Day1-1 Hour/EOI
|
2711 Nanogram per milliliter
Geometric Coefficient of Variation 44
|
2453 Nanogram per milliliter
Geometric Coefficient of Variation 34
|
9984 Nanogram per milliliter
Geometric Coefficient of Variation 39
|
7279 Nanogram per milliliter
Geometric Coefficient of Variation 29
|
36930 Nanogram per milliliter
Geometric Coefficient of Variation 14
|
39590 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of PF-04518600 in Combination D
Cycle 6/Day1-1 Hour/EOI
|
2633 Nanogram per milliliter
Geometric Coefficient of Variation 27
|
2704 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
13340 Nanogram per milliliter
Geometric Coefficient of Variation 27
|
6637 Nanogram per milliliter
Geometric Coefficient of Variation 20
|
34540 Nanogram per milliliter
Geometric Coefficient of Variation 24
|
36190 Nanogram per milliliter
Geometric Coefficient of Variation 20
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of PF-04518600 in Combination D
Cycle 10/Day1-1 Hour/EOI
|
2741 Nanogram per milliliter
Geometric Coefficient of Variation 20
|
2685 Nanogram per milliliter
Geometric Coefficient of Variation 50
|
11130 Nanogram per milliliter
Geometric Coefficient of Variation 44
|
9026 Nanogram per milliliter
Geometric Coefficient of Variation 61
|
44170 Nanogram per milliliter
Geometric Coefficient of Variation 16
|
39190 Nanogram per milliliter
Geometric Coefficient of Variation 43
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1-hour post-infusion (i.e. at the end of infusion) on Days 1 and 15 of Cycle 1 (non-dosing); Day 1 of Cycles 2, 4, 6 and Cycle 10Population: PK analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK concentrations of interest for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points.
Cmax is maximum observed plasma concentration.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=6 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=6 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=6 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination F
Cycle 1/Day1-1 Hour/EOI
|
161.2 Nanogram per milliliter
Geometric Coefficient of Variation 14
|
166.1 Nanogram per milliliter
Geometric Coefficient of Variation 15
|
180.7 Nanogram per milliliter
Geometric Coefficient of Variation 49
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination F
Cycle 1/Day15-1 Hour/EOI
|
182.6 Nanogram per milliliter
Geometric Coefficient of Variation 11
|
171.2 Nanogram per milliliter
Geometric Coefficient of Variation 27
|
151.6 Nanogram per milliliter
Geometric Coefficient of Variation 16
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination F
Cycle 2/Day1-1 Hour/EOI
|
165.5 Nanogram per milliliter
Geometric Coefficient of Variation 10
|
176.7 Nanogram per milliliter
Geometric Coefficient of Variation 22
|
171.0 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination F
Cycle 4/Day1-1 Hour/EOI
|
185.0 Nanogram per milliliter
Geometric Coefficient of Variation 24
|
203.9 Nanogram per milliliter
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination F
Cycle 6/Day1-1 Hour/EOI
|
229.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
|
174.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination F
Cycle 10/Day1-1 Hour/EOI
|
191.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Days 1 and 15 of Cycle 1, Day 8 of Cycle 1 (non-dosing) and then Day 1 of Cycles 2,4,6 and Cycle 10. For ''Phase 2 1L NSCLC: Utomilumab then Utomilumab + Avelumab'' reporting group: Day 1 of Cycles 2,4,6,10Population: All participants who received at least one dose of study drug and who had at least one of the PK concentrations for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points. For ''Phase 2 1L NSCLC: Utomilumab then Utomilumab + Avelumab'' reporting group PK sampling started from Cycle 2 Day 1.
Ctrough is steady-state pre-dose concentration.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=27 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=27 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=29 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=27 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=33 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=20 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=9 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
n=20 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
n=9 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=11 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination A
Cycle 1/Day1-0 Hour
|
9.510 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above lower limit of quantification (LLoQ). Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
5.532 Nanogram per milliliter
Geometric Coefficient of Variation 540
|
16.24 Nanogram per milliliter
Geometric Coefficient of Variation 19873078
|
64.96 Nanogram per milliliter
Geometric Coefficient of Variation 162
|
93.02 Nanogram per milliliter
Geometric Coefficient of Variation 190
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
9.440 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
3.082 Nanogram per milliliter
Geometric Coefficient of Variation 80
|
—
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination A
Cycle 1/Day15-0 Hour
|
22.13 Nanogram per milliliter
Geometric Coefficient of Variation 106
|
17.85 Nanogram per milliliter
Geometric Coefficient of Variation 135
|
19.92 Nanogram per milliliter
Geometric Coefficient of Variation 102
|
22.02 Nanogram per milliliter
Geometric Coefficient of Variation 138
|
23.03 Nanogram per milliliter
Geometric Coefficient of Variation 74
|
25.53 Nanogram per milliliter
Geometric Coefficient of Variation 38
|
18.37 Nanogram per milliliter
Geometric Coefficient of Variation 53
|
13.15 Nanogram per milliliter
Geometric Coefficient of Variation 45
|
—
|
9.781 Nanogram per milliliter
Geometric Coefficient of Variation 84
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination A
Cycle 2/Day1-0 Hour
|
23.14 Nanogram per milliliter
Geometric Coefficient of Variation 84
|
20.69 Nanogram per milliliter
Geometric Coefficient of Variation 115
|
22.67 Nanogram per milliliter
Geometric Coefficient of Variation 105
|
25.45 Nanogram per milliliter
Geometric Coefficient of Variation 224
|
23.35 Nanogram per milliliter
Geometric Coefficient of Variation 77
|
27.94 Nanogram per milliliter
Geometric Coefficient of Variation 43
|
21.61 Nanogram per milliliter
Geometric Coefficient of Variation 76
|
12.52 Nanogram per milliliter
Geometric Coefficient of Variation 80
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
10.96 Nanogram per milliliter
Geometric Coefficient of Variation 110
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination A
Cycle 4/Day1-0 Hour
|
18.79 Nanogram per milliliter
Geometric Coefficient of Variation 132
|
21.53 Nanogram per milliliter
Geometric Coefficient of Variation 103
|
32.46 Nanogram per milliliter
Geometric Coefficient of Variation 74
|
49.20 Nanogram per milliliter
Geometric Coefficient of Variation 259
|
23.30 Nanogram per milliliter
Geometric Coefficient of Variation 59
|
26.82 Nanogram per milliliter
Geometric Coefficient of Variation 55
|
20.21 Nanogram per milliliter
Geometric Coefficient of Variation 86
|
26.50 Nanogram per milliliter
Geometric Coefficient of Variation 85
|
10.52 Nanogram per milliliter
Geometric Coefficient of Variation 140
|
15.38 Nanogram per milliliter
Geometric Coefficient of Variation 81
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination A
Cycle 6/Day1-0 Hour
|
24.80 Nanogram per milliliter
Geometric Coefficient of Variation 52
|
27.33 Nanogram per milliliter
Geometric Coefficient of Variation 99
|
33.45 Nanogram per milliliter
Geometric Coefficient of Variation 40
|
59.47 Nanogram per milliliter
Geometric Coefficient of Variation 105
|
24.28 Nanogram per milliliter
Geometric Coefficient of Variation 65
|
26.17 Nanogram per milliliter
Geometric Coefficient of Variation 57
|
20.66 Nanogram per milliliter
Geometric Coefficient of Variation 9
|
27.62 Nanogram per milliliter
Geometric Coefficient of Variation 73
|
22.16 Nanogram per milliliter
Geometric Coefficient of Variation 43
|
21.05 Nanogram per milliliter
Geometric Coefficient of Variation 45
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination A
Cycle 10/Day1-0 Hour
|
27.56 Nanogram per milliliter
Geometric Coefficient of Variation 46
|
26.87 Nanogram per milliliter
Geometric Coefficient of Variation 100
|
40.42 Nanogram per milliliter
Geometric Coefficient of Variation 66
|
39.89 Nanogram per milliliter
Geometric Coefficient of Variation 24
|
34.09 Nanogram per milliliter
Geometric Coefficient of Variation 52
|
25.31 Nanogram per milliliter
Geometric Coefficient of Variation 101
|
—
|
34.90 Nanogram per milliliter
Geometric Coefficient of Variation 47
|
19.04 Nanogram per milliliter
Geometric Coefficient of Variation 117
|
19.41 Nanogram per milliliter
Geometric Coefficient of Variation 24
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1,3,5,8, and Cycle 12; Day 15 of Cycle 1 (non-dosing). For ''Phase 2 1L NSCLC: Avelumab then Utomilumab + Avelumab'' reporting group: Day 1 of Cycles 3,5,8 and 12Population: All participants who received at least one dose of study drug and who had at least one of the PK concentrations for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points. For participants of ''Phase 2 1L NSCLC: Avelumab then Utomilumab + Avelumab'' reporting group PK sampling started from Cycle 3 Day 1.
Ctrough is steady-state pre-dose concentration.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=28 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=27 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=29 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=28 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=33 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=21 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=10 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
n=20 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
n=10 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=8 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination A
Cycle 8/Day1-0 Hour
|
1840 Nanogram per milliliter
Geometric Coefficient of Variation 54
|
1726 Nanogram per milliliter
Geometric Coefficient of Variation 21
|
839.9 Nanogram per milliliter
Geometric Coefficient of Variation 38
|
1747 Nanogram per milliliter
Geometric Coefficient of Variation 19
|
2300 Nanogram per milliliter
Geometric Coefficient of Variation 138
|
1196 Nanogram per milliliter
Geometric Coefficient of Variation 29
|
1030 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
1070 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
669.0 Nanogram per milliliter
Geometric Coefficient of Variation 27
|
851.8 Nanogram per milliliter
Geometric Coefficient of Variation 30
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination A
Cycle 1/Day1-0 Hour
|
619.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
1430 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
931.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above lower limit of quantification (LLoQ). Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
24400 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
20500 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination A
Cycle 1/Day15-0 Hour
|
2723 Nanogram per milliliter
Geometric Coefficient of Variation 28
|
1536 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
779.3 Nanogram per milliliter
Geometric Coefficient of Variation 25
|
1443 Nanogram per milliliter
Geometric Coefficient of Variation 20
|
1688 Nanogram per milliliter
Geometric Coefficient of Variation 23
|
2323 Nanogram per milliliter
Geometric Coefficient of Variation 30
|
2509 Nanogram per milliliter
Geometric Coefficient of Variation 28
|
2529 Nanogram per milliliter
Geometric Coefficient of Variation 49
|
4283 Nanogram per milliliter
Geometric Coefficient of Variation 42
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination A
Cycle 3/Day1-0 Hour
|
2114 Nanogram per milliliter
Geometric Coefficient of Variation 30
|
982.3 Nanogram per milliliter
Geometric Coefficient of Variation 29
|
743.2 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
1627 Nanogram per milliliter
Geometric Coefficient of Variation 145
|
1547 Nanogram per milliliter
Geometric Coefficient of Variation 72
|
1351 Nanogram per milliliter
Geometric Coefficient of Variation 38
|
693.5 Nanogram per milliliter
Geometric Coefficient of Variation 29
|
1114 Nanogram per milliliter
Geometric Coefficient of Variation 38
|
928.0 Nanogram per milliliter
Geometric Coefficient of Variation 69
|
780.4 Nanogram per milliliter
Geometric Coefficient of Variation 48
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination A
Cycle 5/Day1-0 Hour
|
2259 Nanogram per milliliter
Geometric Coefficient of Variation 53
|
1059 Nanogram per milliliter
Geometric Coefficient of Variation 63
|
931.9 Nanogram per milliliter
Geometric Coefficient of Variation 97
|
1281 Nanogram per milliliter
Geometric Coefficient of Variation 33
|
1366 Nanogram per milliliter
Geometric Coefficient of Variation 37
|
1417 Nanogram per milliliter
Geometric Coefficient of Variation 25
|
855.1 Nanogram per milliliter
Geometric Coefficient of Variation 14
|
1046 Nanogram per milliliter
Geometric Coefficient of Variation 30
|
906.7 Nanogram per milliliter
Geometric Coefficient of Variation 67
|
671.9 Nanogram per milliliter
Geometric Coefficient of Variation 38
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination A
Cycle 12/Day1-0 Hour
|
1814 Nanogram per milliliter
Geometric Coefficient of Variation 52
|
1171 Nanogram per milliliter
Geometric Coefficient of Variation 24
|
690.2 Nanogram per milliliter
Geometric Coefficient of Variation 35
|
1172 Nanogram per milliliter
Geometric Coefficient of Variation 39
|
610.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
1359 Nanogram per milliliter
Geometric Coefficient of Variation 5
|
—
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \<=2 participants, and no observation was equal or above LLoQ . Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
655.4 Nanogram per milliliter
Geometric Coefficient of Variation 64
|
653.9 Nanogram per milliliter
Geometric Coefficient of Variation 23
|
SECONDARY outcome
Timeframe: Pre-dose on Days 1 and 15 of Cycle 1 (non-dosing); Day 1 of Cycles 2, 4, 6 and Cycle 10Population: Pharmacokinetic (PK) analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK concentrations of interest for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points.
Ctrough is steady-state pre-dose concentration.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=12 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=8 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=14 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=25 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PF-04518600 in Combination B
Avelumab Cycle 6/Day1-0 Hour
|
—
|
16.00 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
—
|
29.83 Nanogram per milliliter
Geometric Coefficient of Variation 34
|
25.82 Nanogram per milliliter
Geometric Coefficient of Variation 37
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PF-04518600 in Combination B
PF-04518600 Cycle 10/Day1-0 Hour
|
—
|
—
|
—
|
8097 Nanogram per milliliter
Geometric Coefficient of Variation 59
|
5484 Nanogram per milliliter
Geometric Coefficient of Variation 16
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PF-04518600 in Combination B
Avelumab Cycle 1/Day1-0 Hour
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
228.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PF-04518600 in Combination B
Avelumab Cycle 1/Day15-0 Hour
|
19.05 Nanogram per milliliter
Geometric Coefficient of Variation 69
|
16.83 Nanogram per milliliter
Geometric Coefficient of Variation 63
|
19.88 Nanogram per milliliter
Geometric Coefficient of Variation 50
|
21.72 Nanogram per milliliter
Geometric Coefficient of Variation 54
|
17.00 Nanogram per milliliter
Geometric Coefficient of Variation 63
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PF-04518600 in Combination B
Avelumab Cycle 2/Day1-0 Hour
|
21.10 Nanogram per milliliter
Geometric Coefficient of Variation 84
|
21.27 Nanogram per milliliter
Geometric Coefficient of Variation 47
|
22.04 Nanogram per milliliter
Geometric Coefficient of Variation 70
|
25.32 Nanogram per milliliter
Geometric Coefficient of Variation 59
|
18.77 Nanogram per milliliter
Geometric Coefficient of Variation 92
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PF-04518600 in Combination B
Avelumab Cycle 4/Day1-0 Hour
|
15.72 Nanogram per milliliter
Geometric Coefficient of Variation 179
|
21.16 Nanogram per milliliter
Geometric Coefficient of Variation 13
|
22.37 Nanogram per milliliter
Geometric Coefficient of Variation 91
|
22.69 Nanogram per milliliter
Geometric Coefficient of Variation 46
|
17.95 Nanogram per milliliter
Geometric Coefficient of Variation 90
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PF-04518600 in Combination B
Avelumab Cycle 10/Day1-0 Hour
|
—
|
—
|
—
|
26.30 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
23.70 Nanogram per milliliter
Geometric Coefficient of Variation 24
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PF-04518600 in Combination B
PF-04518600 Cycle 1/Day1-0 Hour
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
5750 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
23.10 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PF-04518600 in Combination B
PF-04518600 Cycle 1/Day15-0 Hour
|
1497 Nanogram per milliliter
Geometric Coefficient of Variation 55
|
6234 Nanogram per milliliter
Geometric Coefficient of Variation 50
|
25320 Nanogram per milliliter
Geometric Coefficient of Variation 29
|
1758 Nanogram per milliliter
Geometric Coefficient of Variation 59
|
1702 Nanogram per milliliter
Geometric Coefficient of Variation 50
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PF-04518600 in Combination B
PF-04518600 Cycle 2/Day1-0 Hour
|
1826 Nanogram per milliliter
Geometric Coefficient of Variation 176
|
11000 Nanogram per milliliter
Geometric Coefficient of Variation 23
|
31830 Nanogram per milliliter
Geometric Coefficient of Variation 99
|
2928 Nanogram per milliliter
Geometric Coefficient of Variation 39
|
2327 Nanogram per milliliter
Geometric Coefficient of Variation 58
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PF-04518600 in Combination B
PF-04518600 Cycle 4/Day1-0 Hour
|
2324 Nanogram per milliliter
Geometric Coefficient of Variation 235
|
—
|
79790 Nanogram per milliliter
Geometric Coefficient of Variation 28
|
4799 Nanogram per milliliter
Geometric Coefficient of Variation 47
|
5129 Nanogram per milliliter
Geometric Coefficient of Variation 43
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PF-04518600 in Combination B
PF-04518600 Cycle 6/Day1-0 Hour
|
—
|
17200 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
—
|
6577 Nanogram per milliliter
Geometric Coefficient of Variation 37
|
6508 Nanogram per milliliter
Geometric Coefficient of Variation 23
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Days 1 and 15 of Cycle 1 (non-dosing); Day 1 of Cycles 2, 4, 6 and Cycle 10Population: PK analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK concentrations of interest for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points.
Ctrough is steady-state pre-dose concentration.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=10 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=8 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=6 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PD 0360324 in Combination C
PD 0360324 Cycle 4/Day1-0 Hour
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \<=2 participants, and no observation was equal or above LLoQ . Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
447.2 Nanogram per milliliter
Geometric Coefficient of Variation 62
|
1397 Nanogram per milliliter
Geometric Coefficient of Variation 190
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PD 0360324 in Combination C
Avelumab Cycle 1/Day1-0 Hour
|
0.2090 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PD 0360324 in Combination C
Avelumab Cycle 1/Day15-0 Hour
|
20.45 Nanogram per milliliter
Geometric Coefficient of Variation 39
|
32.34 Nanogram per milliliter
Geometric Coefficient of Variation 40
|
22.53 Nanogram per milliliter
Geometric Coefficient of Variation 63
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PD 0360324 in Combination C
Avelumab Cycle 2/Day1-0 Hour
|
16.35 Nanogram per milliliter
Geometric Coefficient of Variation 136
|
31.44 Nanogram per milliliter
Geometric Coefficient of Variation 98
|
15.94 Nanogram per milliliter
Geometric Coefficient of Variation 237
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PD 0360324 in Combination C
Avelumab Cycle 4/Day1-0 Hour
|
15.50 Nanogram per milliliter
Geometric Coefficient of Variation 23
|
57.13 Nanogram per milliliter
Geometric Coefficient of Variation 80
|
36.04 Nanogram per milliliter
Geometric Coefficient of Variation 37
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PD 0360324 in Combination C
Avelumab Cycle 6/Day1-0 Hour
|
26.38 Nanogram per milliliter
Geometric Coefficient of Variation 24
|
77.20 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
33.23 Nanogram per milliliter
Geometric Coefficient of Variation 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PD 0360324 in Combination C
Avelumab Cycle 10/Day1-0 Hour
|
—
|
46.90 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
27.09 Nanogram per milliliter
Geometric Coefficient of Variation 4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PD 0360324 in Combination C
PD 0360324 Cycle 1/Day1-0 Hour
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PD 0360324 in Combination C
PD 0360324 Cycle 1/Day15-0 Hour
|
126.2 Nanogram per milliliter
Geometric Coefficient of Variation 20
|
390.9 Nanogram per milliliter
Geometric Coefficient of Variation 94
|
583.1 Nanogram per milliliter
Geometric Coefficient of Variation 101
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PD 0360324 in Combination C
PD 0360324 Cycle 2/Day1-0 Hour
|
137.7 Nanogram per milliliter
Geometric Coefficient of Variation 46
|
360.4 Nanogram per milliliter
Geometric Coefficient of Variation 110
|
2987 Nanogram per milliliter
Geometric Coefficient of Variation 105
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PD 0360324 in Combination C
PD 0360324 Cycle 6/Day1-0 Hour
|
134.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
654.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
312.1 Nanogram per milliliter
Geometric Coefficient of Variation 128
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PD 0360324 in Combination C
PD 0360324 Cycle 10/Day1-0 Hour
|
—
|
115.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
169.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycle 1, 2, 4, 6 and Cycle 10; Day 15 of Cycle 1 (non-dosing)Population: PK analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK concentrations of interest for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points.
Ctrough is steady-state pre-dose concentration.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=11 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=11 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination D
Cycle 6/Day1-0 Hour
|
30.03 Nanogram per milliliter
Geometric Coefficient of Variation 52
|
31.36 Nanogram per milliliter
Geometric Coefficient of Variation 59
|
18.87 Nanogram per milliliter
Geometric Coefficient of Variation 17
|
27.05 Nanogram per milliliter
Geometric Coefficient of Variation 1
|
33.12 Nanogram per milliliter
Geometric Coefficient of Variation 36
|
25.26 Nanogram per milliliter
Geometric Coefficient of Variation 8
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination D
Cycle 10/Day1-0 Hour
|
32.84 Nanogram per milliliter
Geometric Coefficient of Variation 48
|
36.98 Nanogram per milliliter
Geometric Coefficient of Variation 32
|
18.39 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
35.08 Nanogram per milliliter
Geometric Coefficient of Variation 14
|
26.33 Nanogram per milliliter
Geometric Coefficient of Variation 29
|
39.35 Nanogram per milliliter
Geometric Coefficient of Variation 28
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination D
Cycle 1/Day1-0 Hour
|
6.200 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination D
Cycle 1/Day15-0 Hour
|
17.61 Nanogram per milliliter
Geometric Coefficient of Variation 54
|
13.22 Nanogram per milliliter
Geometric Coefficient of Variation 35
|
13.48 Nanogram per milliliter
Geometric Coefficient of Variation 38
|
17.52 Nanogram per milliliter
Geometric Coefficient of Variation 16
|
14.42 Nanogram per milliliter
Geometric Coefficient of Variation 78
|
9.445 Nanogram per milliliter
Geometric Coefficient of Variation 102
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination D
Cycle 2/Day1-0 Hour
|
16.04 Nanogram per milliliter
Geometric Coefficient of Variation 116
|
11.04 Nanogram per milliliter
Geometric Coefficient of Variation 178
|
17.23 Nanogram per milliliter
Geometric Coefficient of Variation 31
|
11.93 Nanogram per milliliter
Geometric Coefficient of Variation 95
|
22.29 Nanogram per milliliter
Geometric Coefficient of Variation 32
|
13.19 Nanogram per milliliter
Geometric Coefficient of Variation 94
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination D
Cycle 4/Day1-0 Hour
|
26.76 Nanogram per milliliter
Geometric Coefficient of Variation 69
|
31.10 Nanogram per milliliter
Geometric Coefficient of Variation 54
|
17.77 Nanogram per milliliter
Geometric Coefficient of Variation 27
|
24.73 Nanogram per milliliter
Geometric Coefficient of Variation 20
|
29.11 Nanogram per milliliter
Geometric Coefficient of Variation 32
|
27.00 Nanogram per milliliter
Geometric Coefficient of Variation 10
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycle 1, 3, 5, 8 and Cycle 12; Day 15 of Cycle 1 (non-dosing)Population: PK analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK concentrations of interest for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points.
Ctrough is steady-state pre-dose concentration.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=11 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=11 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=11 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination D
Cycle 8/Day1-0 Hour
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \<=2 participants, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
730.5 Nanogram per milliliter
Geometric Coefficient of Variation 23
|
674.3 Nanogram per milliliter
Geometric Coefficient of Variation 41
|
1440 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \<=2 participants, and no observation was equal or above LLoQ . Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination D
Cycle 12/Day1-0 Hour
|
407.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
720.9 Nanogram per milliliter
Geometric Coefficient of Variation 25
|
794.2 Nanogram per milliliter
Geometric Coefficient of Variation 105
|
985.6 Nanogram per milliliter
Geometric Coefficient of Variation 81
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \<=2 participants, and no observation was equal or above LLoQ . Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination D
Cycle 1/Day1-0 Hour
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination D
Cycle 1/Day15-0 Hour
|
616.5 Nanogram per milliliter
Geometric Coefficient of Variation 41
|
1353 Nanogram per milliliter
Geometric Coefficient of Variation 24
|
726.4 Nanogram per milliliter
Geometric Coefficient of Variation 19
|
1649 Nanogram per milliliter
Geometric Coefficient of Variation 34
|
595.2 Nanogram per milliliter
Geometric Coefficient of Variation 23
|
1752 Nanogram per milliliter
Geometric Coefficient of Variation 16
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination D
Cycle 3/Day1-0 Hour
|
561.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
846.0 Nanogram per milliliter
Geometric Coefficient of Variation 54
|
516.6 Nanogram per milliliter
Geometric Coefficient of Variation 31
|
602.2 Nanogram per milliliter
Geometric Coefficient of Variation 38
|
813.3 Nanogram per milliliter
Geometric Coefficient of Variation 28
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination D
Cycle 5/Day1-0 Hour
|
712.3 Nanogram per milliliter
Geometric Coefficient of Variation 11
|
718.1 Nanogram per milliliter
Geometric Coefficient of Variation 34
|
505.0 Nanogram per milliliter
Geometric Coefficient of Variation 23
|
422.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
763.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 and 15 of Cycle 1 (non-dosing); Pre-dose on Day 1 of Cycle 2, 4, 6 and Cycle 10Population: PK analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK concentrations of interest for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points.
Ctrough is steady-state pre-dose concentration.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=11 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=11 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=11 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=11 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of PF-04518600 in Combination D
Cycle 1/Day1-0 Hour
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of PF-04518600 in Combination D
Cycle 1/Day15-0 Hour
|
320.2 Nanogram per milliliter
Geometric Coefficient of Variation 86
|
144.2 Nanogram per milliliter
Geometric Coefficient of Variation 128
|
1342 Nanogram per milliliter
Geometric Coefficient of Variation 50
|
1529 Nanogram per milliliter
Geometric Coefficient of Variation 31
|
6388 Nanogram per milliliter
Geometric Coefficient of Variation 22
|
5466 Nanogram per milliliter
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of PF-04518600 in Combination D
Cycle 2/Day1-0 Hour
|
426.0 Nanogram per milliliter
Geometric Coefficient of Variation 48
|
192.6 Nanogram per milliliter
Geometric Coefficient of Variation 168
|
1823 Nanogram per milliliter
Geometric Coefficient of Variation 121
|
2164 Nanogram per milliliter
Geometric Coefficient of Variation 31
|
11470 Nanogram per milliliter
Geometric Coefficient of Variation 19
|
8241 Nanogram per milliliter
Geometric Coefficient of Variation 86
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of PF-04518600 in Combination D
Cycle 4/Day1-0 Hour
|
891.8 Nanogram per milliliter
Geometric Coefficient of Variation 60
|
656.8 Nanogram per milliliter
Geometric Coefficient of Variation 101
|
4524 Nanogram per milliliter
Geometric Coefficient of Variation 32
|
3506 Nanogram per milliliter
Geometric Coefficient of Variation 38
|
24010 Nanogram per milliliter
Geometric Coefficient of Variation 16
|
21500 Nanogram per milliliter
Geometric Coefficient of Variation 12
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of PF-04518600 in Combination D
Cycle 6/Day1-0 Hour
|
1033 Nanogram per milliliter
Geometric Coefficient of Variation 84
|
793.4 Nanogram per milliliter
Geometric Coefficient of Variation 110
|
6712 Nanogram per milliliter
Geometric Coefficient of Variation 22
|
3971 Nanogram per milliliter
Geometric Coefficient of Variation 17
|
21990 Nanogram per milliliter
Geometric Coefficient of Variation 56
|
20230 Nanogram per milliliter
Geometric Coefficient of Variation 18
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of PF-04518600 in Combination D
Cycle 10/Day1-0 Hour
|
1444 Nanogram per milliliter
Geometric Coefficient of Variation 25
|
829.8 Nanogram per milliliter
Geometric Coefficient of Variation 181
|
6900 Nanogram per milliliter
Geometric Coefficient of Variation 65
|
4834 Nanogram per milliliter
Geometric Coefficient of Variation 76
|
24880 Nanogram per milliliter
Geometric Coefficient of Variation 19
|
22620 Nanogram per milliliter
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 and 15 of Cycle 1 (non-dosing); Pre-dose on Day 1 of Cycle 2, 4, 6 and Cycle 10Population: PK analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK concentrations of interest for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points.
Ctrough is steady-state pre-dose concentration.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=6 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=7 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=6 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination F
Cycle 1/Day1-0 Hour
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
14.30 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination F
Cycle 1/Day15-0 Hour
|
16.32 Nanogram per milliliter
Geometric Coefficient of Variation 71
|
21.26 Nanogram per milliliter
Geometric Coefficient of Variation 18
|
18.53 Nanogram per milliliter
Geometric Coefficient of Variation 68
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination F
Cycle 2/Day1-0 Hour
|
10.97 Nanogram per milliliter
Geometric Coefficient of Variation 137
|
16.76 Nanogram per milliliter
Geometric Coefficient of Variation 122
|
18.17 Nanogram per milliliter
Geometric Coefficient of Variation 130
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination F
Cycle 4/Day1-0 Hour
|
40.90 Nanogram per milliliter
Geometric Coefficient of Variation 20
|
24.36 Nanogram per milliliter
Geometric Coefficient of Variation 69
|
24.00 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination F
Cycle 6/Day1-0 Hour
|
37.00 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
31.90 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination F
Cycle 10/Day1-0 Hour
|
30.40 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
30.50 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycle 1 (non-dosing); Pre-dose on Day 1 of Cycle 2 and 4Population: PK analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK concentrations of interest for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points.
Ctrough is steady-state pre-dose concentration.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=7 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination F
Cycle 1/Day1-0 Hour
|
—
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination F
Cycle 2/Day1-0 Hour
|
—
|
748.9 Nanogram per milliliter
Geometric Coefficient of Variation 25
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination F
Cycle 4/Day1-0 Hour
|
—
|
866.0 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycle 1 (non-dosing); Pre-dose on Day 1 of Cycles 2 and 4Population: PK analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK concentrations of interest for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points.
Ctrough is steady-state pre-dose concentration.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=6 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of PF-04518600 in Combination F
Cycle 1/Day1-0 Hour
|
—
|
—
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of PF-04518600 in Combination F
Cycle 2/Day1-0 Hour
|
—
|
—
|
2179 Nanogram per milliliter
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Observed Plasma Concentration (Ctrough) of PF-04518600 in Combination F
Cycle 4/Day1-0 Hour
|
—
|
—
|
3610 Nanogram per milliliter
Geometric Coefficient of Variation NA
Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycle 1, 2, 4, 6, 10. For ''Phase 2 1L NSCLC: Utomilumab then Utomilumab + Avelumab'' reporting group: Day 1 of Cycle 2, 4, 6, 10Population: The analysis population was a subset of the safety analysis set (all participants who received at least one dose of study drug) and included participants who had at least one ADA sample collected for avelumab. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
ADA ever-positive was defined as at least one positive ADA result at any time point.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=29 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=141 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=29 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=11 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=11 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Anti-Drug Antibody (ADA) Against Avelumab For Combination A
|
3 Participants
|
13 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycle 1, 3, 5, 8, 12. For ''Phase 2 1L NSCLC: Avelumab then Utomilumab + Avelumab'' reporting group: Day 1 of Cycle 3, 5, 8, 12Population: The analysis population was a subset of the safety analysis set (all participants who received at least one dose of study drug) and included participants who had at least one ADA sample collected for avelumab. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
ADA ever-positive was defined as at least one positive ADA result at any time point.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=29 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=141 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=29 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=10 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=9 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive ADA Levels Against Utomilumab For Combination A
|
6 Participants
|
51 Participants
|
16 Participants
|
7 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycle 1, 2, 4, 6, and 10Population: The analysis population was a subset of the safety analysis set (all participants who received at least one dose of study drug) and included participants who had at least one ADA sample collected for avelumab. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
ADA ever-positive was defined as at least one positive ADA result at any time point.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=51 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=8 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive ADA Levels For Combination B
ADA ever-positive -Avelumab
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADA Levels For Combination B
ADA ever-positive - PF-04518600
|
19 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycle 1, 2, 4, 6, and 10Population: The analysis population was a subset of the safety analysis set (all participants who received at least one dose of study drug) and included participants who had at least one ADA sample collected for avelumab. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
ADA ever-positive was defined as at least one positive ADA result at any time point.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=10 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=8 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=6 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive ADA Levels For Combination C
ADA ever-positive -Avelumab
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADA Levels For Combination C
ADA ever-positive -PD 0360324
|
0 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycle 1, 2, 4, 6, and 10Population: The analysis population was a subset of the safety analysis set (all participants who received at least one dose of study drug) and included participants who had at least one ADA sample collected for avelumab. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
ADA ever-positive was defined as at least one positive ADA result at any time point.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=12 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=11 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive ADA Levels Against Avelumab and PF-04518600 For Combination D
ADA ever-positive -Avelumab
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADA Levels Against Avelumab and PF-04518600 For Combination D
ADA ever-positive -PF-04518600
|
5 Participants
|
7 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycle 1, 3, 5, 8, 12Population: The analysis population was a subset of the safety analysis set (all participants who received at least one dose of study drug) and included participants who had at least one ADA sample collected for avelumab. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
ADA ever-positive was defined as at least one positive ADA result at any time point.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=12 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=11 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive ADA Levels Against Utomilumab For Combination D
|
3 Participants
|
4 Participants
|
7 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycle 1, 2, 4, 6, and 10Population: Analysis population was subset of safety analysis set (participants who received at least one dose of study drug) and included participants who had at least one ADA sample collected for avelumab. There was no evaluable participant for PF-04518600 ADA for arms "Phase 1b SCCHN CMP-001 10 mg + Avelumab" and "Phase 1b SCCHN CMP-001 10 mg then Avelumab + Utomilumab 100 mg." Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
ADA ever-positive was defined as at least one positive ADA result at any time point.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=6 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=7 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=7 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive ADA Levels Against Avelumab and PF-04518600 For Combination F
ADA ever-positive -Avelumab
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADA Levels Against Avelumab and PF-04518600 For Combination F
ADA ever-positive - PF-04518600
|
—
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycle 1, 2, 4, 6, and 10Population: Analysis population was subset of safety analysis set (participants who received at least one dose of study drug) and included participants who had at least one ADA sample collected for avelumab. There was no evaluable participant for PF-04518600 ADA for arms "Phase 1b SCCHN CMP-001 10 mg + Avelumab" and "Phase 1b SCCHN CMP-001 10 mg then Avelumab + PF-04518600 0.3 mg/kg." Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
ADA ever-positive was defined as at least one positive ADA result at any time point.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=7 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive ADA Levels Against Utomilumab For Combination F
|
0 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until first documentation of CR or PR (maximum up to 7.3 years)Population: Analysis population included all participants who received at least one dose of study drug and who had confirmed CR or PR. Participants were classified according to study treatment actually received. If participant received more than one treatment, participant was classified according to first treatment received. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure with at least 1 confirmed complete response or partial response.
TTR was defined, for participants with an objective response (confirmed CR or PR), as the time from the start date (the date of first dose of treatment) to the first documentation of objective response (CR or PR) which was subsequently confirmed. Per RECIST v1.1: CR: disappearance of all non-nodal target lesions and of all non-target lesions. In addition, any pathological lymph nodes assigned as target lesions/ non-target lesions must have a reduction in short axis to \<10 mm. PR: at least a 30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=1 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=3 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=3 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=3 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=3 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=1 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
n=1 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
n=6 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=2 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Tumor Response (TTR) for Combination A
|
3.6 Months
Interval 3.6 to 3.6
|
—
|
1.9 Months
Interval 1.7 to 11.3
|
1.9 Months
Interval 1.8 to 7.4
|
1.8 Months
Interval 1.5 to 3.5
|
1.7 Months
Interval 1.6 to 1.7
|
1.7 Months
Interval 1.7 to 1.7
|
1.6 Months
Interval 1.6 to 1.6
|
3.7 Months
Interval 1.8 to 7.4
|
2.7 Months
Interval 1.6 to 3.7
|
SECONDARY outcome
Timeframe: From first dose of study drug until first documentation of CR or PR (maximum up to 7.3 years)Population: Analysis population included all participants who received at least one dose of study drug and who had confirmed CR or PR. Participants were classified according to study treatment actually received. If participant received more than one treatment, participant was classified according to first treatment received. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure with at least 1 confirmed complete response or partial response.
TTR was defined, for participants with an objective response (confirmed CR or PR), as the time from the start date (the date of first dose of treatment) to the first documentation of objective response (CR or PR) which was subsequently confirmed. Per RECIST v1.1: CR: disappearance of all non-nodal target lesions and of all non-target lesions. In addition, any pathological lymph nodes assigned as target lesions/ non-target lesions must have a reduction in short axis to \<10 mm. PR: at least a 30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=2 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=2 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
TTR for Combination B
|
—
|
—
|
—
|
2.8 Months
Interval 1.9 to 3.7
|
3.6 Months
Interval 1.7 to 5.6
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until first documentation of CR or PR (maximum up to 7.3 years)Population: Analysis population included all participants who received at least one dose of study drug and who had confirmed CR or PR. Participants were classified according to study treatment actually received. If participant received more than one treatment, participant was classified according to first treatment received. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure with at least 1 confirmed complete response or partial response.
TTR was defined, for participants with an objective response (confirmed CR or PR), as the time from the start date (the date of first dose of treatment) to the first documentation of objective response (CR or PR) which was subsequently confirmed. Per RECIST v1.1: CR: disappearance of all non-nodal target lesions and of all non-target lesions. In addition, any pathological lymph nodes assigned as target lesions/ non-target lesions must have a reduction in short axis to \<10 mm. PR: at least a 30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=1 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=2 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=1 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
TTR for Combination C
|
4.0 Months
Interval 4.0 to 4.0
|
2.8 Months
Interval 2.2 to 3.5
|
9.4 Months
Interval 9.4 to 9.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until first documentation of CR or PR (maximum up to 7.3 years)Population: Analysis population included all participants who received at least one dose of study drug and who had confirmed CR or PR. Participants were classified according to study treatment actually received. If participant received more than one treatment, participant was classified according to first treatment received. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure with at least 1 confirmed complete response or partial response.
TTR was defined, for participants with an objective response (confirmed CR or PR), as the time from the start date (the date of first dose of treatment) to the first documentation of objective response (CR or PR) which was subsequently confirmed. Per RECIST v1.1: CR: disappearance of all non-nodal target lesions and of all non-target lesions. In addition, any pathological lymph nodes assigned as target lesions/ non-target lesions must have a reduction in short axis to \<10 mm. PR: at least a 30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=1 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=4 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=3 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=1 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=1 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=2 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
TTR for Combination D
|
3.7 Months
Interval 3.7 to 3.7
|
1.7 Months
Interval 1.7 to 3.7
|
1.6 Months
Interval 1.6 to 1.7
|
1.8 Months
Interval 1.8 to 1.8
|
1.8 Months
Interval 1.8 to 1.8
|
2.8 Months
Interval 1.9 to 3.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until first documentation of CR or PR (maximum up to 7.3 years)Population: Analysis population included all participants who received at least one dose of study drug and who had confirmed CR or PR. Participants were classified according to study treatment actually received. If participant received more than one treatment, participant was classified according to first treatment received. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure with at least 1 confirmed complete response or partial response.
TTR was defined, for participants with an objective response (confirmed CR or PR), as the time from the start date (the date of first dose of treatment) to the first documentation of objective response (CR or PR) which was subsequently confirmed. Per RECIST v1.1: CR: disappearance of all non-nodal target lesions and of all non-target lesions. In addition, any pathological lymph nodes assigned as target lesions/ non-target lesions must have a reduction in short axis to \<10 mm. PR: at least a 30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=1 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
TTR for Combination F
|
—
|
4.4 Months
Interval 4.4 to 4.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)Population: Full analysis set includes all randomized participants for Cohorts A1, A2, A3, A9, and A10 and all enrolled participants for Cohorts A4, A5, A6, A7, and A8 who received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
DR as assessed by investigator according to RECIST v1.1, was defined as the time from date of first documentation of objective response (CR or PR) to date of PD or death due to any cause, or data censoring date, whichever occurred first. CR: disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) reduced in short axis to \<10 mm. PR: \>= 30% decrease in sum of diameter of target lesions taking as reference baseline sum diameters. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study treatment, with absolute increase of at least 5 mm or appearance of \>=1 new lesions. DR data was censored on the date of last adequate tumor assessment for participants without an event (CR, PR, PD or death), for participants who start new anti-cancer treatment prior to DR assessment, for participants with DR assessment after \>=2 missing tumor assessments.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=1 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=3 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=3 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=3 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=3 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=1 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
n=1 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
n=6 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=2 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DR) for Combination A
|
12.5 Months
Interval 12.5 to 12.5
|
—
|
27.4 Months
Interval 20.9 to 33.9
|
52.9 Months
Interval 7.9 to 53.2
|
15.8 Months
Interval 5.7 to 29.5
|
28.5 Months
Interval 3.8 to 29.7
|
3.7 Months
Interval 3.7 to 3.7
|
4.9 Months
Interval 4.9 to 4.9
|
8.1 Months
Interval 2.5 to 43.1
|
24.8 Months
Interval 5.6 to 44.0
|
SECONDARY outcome
Timeframe: From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)Population: Full analysis set included all enrolled participants who received at least one dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
DR as assessed by investigator according to RECIST v1.1, was defined as the time from date of first documentation of objective response (CR or PR) to date of PD or death due to any cause, or data censoring date, whichever occurred first. CR: disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) reduced in short axis to \<10 mm. PR: \>= 30% decrease in sum of diameter of target lesions taking as reference baseline sum diameters. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study treatment, with absolute increase of at least 5 mm or appearance of \>=1 new lesions. DR data was censored on the date of last adequate tumor assessment for participants without an event (CR, PR, PD or death), for participants who start new anti-cancer treatment prior to DR assessment, for participants with DR assessment after \>=2 missing tumor assessments.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=2 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=2 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
DR for Combination B
|
—
|
—
|
—
|
5.6 Months
Interval 3.7 to 7.4
|
23.5 Months
Interval 20.9 to 26.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)Population: Full analysis set included all enrolled participants who received at least one dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
DR as assessed by investigator according to RECIST v1.1, was defined as the time from date of first documentation of objective response (CR or PR) to date of PD or death due to any cause, or data censoring date, whichever occurred first. CR: disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) reduced in short axis to \<10 mm. PR: \>= 30% decrease in sum of diameter of target lesions taking as reference baseline sum diameters. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study treatment, with absolute increase of at least 5 mm or appearance of \>=1 new lesions. DR data was censored on the date of last adequate tumor assessment for participants without an event (CR, PR, PD or death), for participants who start new anti-cancer treatment prior to DR assessment, for participants with DR assessment after \>=2 missing tumor assessments.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=1 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=2 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=1 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
DR for Combination C
|
7.1 Months
Interval 7.1 to 7.1
|
7.1 Months
Interval 5.6 to 8.6
|
13.1 Months
Interval 13.1 to 13.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)Population: Full analysis set included all enrolled participants who received at least one dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
DR as assessed by investigator according to RECIST v1.1, was defined as the time from date of first documentation of objective response (CR or PR) to date of PD or death due to any cause, or data censoring date, whichever occurred first. CR: disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) reduced in short axis to \<10 mm. PR: \>= 30% decrease in sum of diameter of target lesions taking as reference baseline sum diameters. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study treatment, with absolute increase of at least 5 mm or appearance of \>=1 new lesions. DR data was censored on the date of last adequate tumor assessment for participants without an event (CR, PR, PD or death), for participants who start new anti-cancer treatment prior to DR assessment, for participants with DR assessment after \>=2 missing tumor assessments.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=1 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=4 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=3 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=1 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=1 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=2 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
DR for Combination D
|
5.5 Months
Interval 5.5 to 5.5
|
28.5 Months
Interval 17.5 to 49.0
|
22.1 Months
Interval 17.8 to 35.3
|
38.6 Months
Interval 38.6 to 38.6
|
26.3 Months
Interval 26.3 to 26.3
|
7.4 Months
Interval 5.6 to 9.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)Population: Full analysis set included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
DR as assessed by investigator according to RECIST v1.1, was defined as the time from date of first documentation of objective response (CR or PR) to date of PD or death due to any cause, or data censoring date, whichever occurred first. CR: disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) reduced in short axis to \<10 mm. PR: \>= 30% decrease in sum of diameter of target lesions taking as reference baseline sum diameters. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study treatment, with absolute increase of at least 5 mm or appearance of \>=1 new lesions. DR data was censored on the date of last adequate tumor assessment for participants without an event (CR, PR, PD or death), for participants who start new anti-cancer treatment prior to DR assessment, for participants with DR assessment after \>=2 missing tumor assessments.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=1 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
DR for Combination F
|
—
|
18.7 Months
Interval 18.7 to 18.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until first documentation of PD or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)Population: Full analysis set includes all randomized participants for Cohorts A1, A2, A3, A9, and A10 and all enrolled participants for Cohorts A4, A5, A6, A7, and A8 who received at least 1 dose of study drug.
PFS as assessed by investigator per RECIST v1.1, was defined as time (in months) from date of first dose of study drug to date of first documentation of PD or death due to any cause or data censoring date, whichever occurred first. PD: \>= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on study treatment (this included baseline sum if that was smallest on study treatment). The sum must also demonstrate absolute increase of \>=5 mm, or appearance of \>=1 new lesions. PFS was analyzed by Kaplan-Meier method. PFS data was censored on the date the last adequate tumor assessment for participants without an event (PD or death), for participants who started new anti-cancer treatment prior to PFS event, for participants with a PFS event after \>=2 missing tumor assessments.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=29 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=28 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=29 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=28 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=35 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=21 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=10 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
n=21 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
n=11 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=11 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) for Combination A
|
2.2 Months
Interval 1.8 to 5.3
|
1.8 Months
Interval 1.7 to 2.3
|
1.9 Months
Interval 1.7 to 3.7
|
1.9 Months
Interval 1.8 to 3.9
|
1.9 Months
Interval 1.8 to 3.7
|
1.8 Months
Interval 1.4 to 5.5
|
1.6 Months
Interval 0.3 to 5.4
|
1.8 Months
Interval 1.7 to 3.6
|
11.9 Months
Interval 4.2 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
5.5 Months
Interval 0.7 to 43.5
|
SECONDARY outcome
Timeframe: From first dose of study drug until first documentation of PD or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)Population: Full analysis set included all enrolled participants who received at least one dose of study drug.
PFS as assessed by investigator per RECIST v1.1, was defined as time (in months) from date of first dose of study drug to date of first documentation of PD or death due to any cause or data censoring date, whichever occurred first. PD: \>= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on study treatment (this included baseline sum if that was smallest on study treatment). The sum must also demonstrate absolute increase of \>=5 mm, or appearance of \>=1 new lesions. PFS was analyzed by Kaplan-Meier method. PFS data was censored on the date the last adequate tumor assessment for participants without an event (PD or death), for participants who started new anti-cancer treatment prior to PFS event, for participants with a PFS event after \>=2 missing tumor assessments.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=12 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=8 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=14 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=25 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PFS for Combination B
|
1.7 Months
Interval 0.7 to 1.8
|
1.8 Months
Interval 1.0 to 2.7
|
1.7 Months
Interval 0.9 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
3.7 Months
Interval 1.8 to 5.6
|
1.8 Months
Interval 1.7 to 2.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until first documentation of PD or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)Population: Full analysis set included all enrolled participants who received at least one dose of study drug.
PFS as assessed by investigator per RECIST v1.1, was defined as time (in months) from date of first dose of study drug to date of first documentation of PD or death due to any cause or data censoring date, whichever occurred first. PD: \>= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on study treatment (this included baseline sum if that was smallest on study treatment). The sum must also demonstrate absolute increase of \>=5 mm, or appearance of \>=1 new lesions. PFS was analyzed by Kaplan-Meier method. PFS data was censored on the date the last adequate tumor assessment for participants without an event (PD or death), for participants who started new anti-cancer treatment prior to PFS event, for participants with a PFS event after \>=2 missing tumor assessments.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=10 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=8 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=6 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PFS for Combination C
|
1.9 Months
Interval 0.5 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
9.0 Months
Interval 1.1 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
12.2 Months
Interval 1.7 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until first documentation of PD or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)Population: Full analysis set included all enrolled participants who received at least one dose of study drug.
PFS as assessed by investigator per RECIST v1.1, was defined as time (in months) from date of first dose of study drug to date of first documentation of PD or death due to any cause or data censoring date, whichever occurred first. PD: \>= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on study treatment (this included baseline sum if that was smallest on study treatment). The sum must also demonstrate absolute increase of \>=5 mm, or appearance of \>=1 new lesions. PFS was analyzed by Kaplan-Meier method. PFS data was censored on the date the last adequate tumor assessment for participants without an event (PD or death), for participants who started new anti-cancer treatment prior to PFS event, for participants with a PFS event after \>=2 missing tumor assessments.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=12 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=11 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PFS for Combination D
|
1.8 Months
Interval 1.1 to 9.2
|
1.8 Months
Interval 1.3 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
3.7 Months
Interval 1.0 to 23.8
|
1.8 Months
Interval 1.2 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
1.8 Months
Interval 1.4 to 3.1
|
1.8 Months
Interval 0.6 to 1.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until first documentation of PD or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)Population: Full analysis set included all randomized participants.
PFS as assessed by investigator per RECIST v1.1, was defined as time (in months) from date of first dose of study drug to date of first documentation of PD or death due to any cause or data censoring date, whichever occurred first. PD: \>= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on study treatment (this included baseline sum if that was smallest on study treatment). The sum must also demonstrate absolute increase of \>=5 mm, or appearance of \>=1 new lesions. PFS was analyzed by Kaplan-Meier method. PFS data was censored on the date the last adequate tumor assessment for participants without an event (PD or death), for participants who started new anti-cancer treatment prior to PFS event, for participants with a PFS event after \>=2 missing tumor assessments.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=6 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=7 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=7 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PFS for Combination F
|
2.3 Months
Interval 1.7 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
1.9 Months
Interval 1.7 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
1.8 Months
Interval 1.3 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug to date of death from any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)Population: Full analysis set includes all randomized participants for Cohorts A1, A2, A3, A9, and A10 and all enrolled participants for Cohorts A4, A5, A6, A7, and A8 who received at least 1 dose of study drug.
OS was defined as the time (in months) from the date of first dose of study drug to the date of death due to any cause or data censoring date, whichever occurred first. Participants last known to be alive were censored at the date of last contact. OS was analyzed by Kaplan-Meier method.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=29 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=28 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=29 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=28 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=35 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=21 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=10 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
n=21 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
n=11 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=11 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) for Combination A
|
14.5 Months
Interval 6.2 to 36.1
|
12.7 Months
Interval 3.0 to 16.1
|
14.7 Months
Interval 6.8 to 22.0
|
8.1 Months
Interval 6.4 to 15.2
|
10.7 Months
Interval 7.7 to 16.9
|
10.9 Months
Interval 4.7 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
11.3 Months
Interval 0.4 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
12.8 Months
Interval 6.9 to 18.9
|
29.3 Months
Interval 5.8 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
22.1 Months
Interval 3.4 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
SECONDARY outcome
Timeframe: From first dose of study drug to date of death from any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)Population: Full analysis set included all enrolled participants who received at least one dose of study drug.
OS was defined as the time (in months) from the date of first dose of study drug to the date of death due to any cause or data censoring date, whichever occurred first. Participants last known to be alive were censored at the date of last contact. OS was analyzed by Kaplan-Meier method.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=12 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=8 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=14 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=25 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
OS for Combination B
|
8.5 Months
Interval 1.6 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
13.5 Months
Interval 4.0 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
7.1 Months
Interval 2.4 to 20.8
|
15.9 Months
Interval 6.3 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
10.7 Months
Interval 6.7 to 14.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug to date of death from any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)Population: Full analysis set included all enrolled participants who received at least one dose of study drug.
OS was defined as the time (in months) from the date of first dose of study drug to the date of death due to any cause or data censoring date, whichever occurred first. Participants last known to be alive were censored at the date of last contact. OS was analyzed by Kaplan-Meier method.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=10 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=8 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=6 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
OS for Combination C
|
16.3 Months
Interval 0.5 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
30.9 Months
Interval 1.1 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
17.3 Months
Interval 6.3 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug to date of death from any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)Population: Full analysis set included all enrolled participants who received at least one dose of study drug.
OS was defined as the time (in months) from the date of first dose of study drug to the date of death due to any cause or data censoring date, whichever occurred first. Participants last known to be alive were censored at the date of last contact. OS was analyzed by Kaplan-Meier method.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=12 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=11 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
OS for Combination D
|
9.4 Months
Interval 3.7 to 23.5
|
7.4 Months
Interval 1.7 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
16.2 Months
Interval 5.1 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
6.1 Months
Interval 1.2 to 22.5
|
8.5 Months
Interval 3.4 to 25.2
|
6.6 Months
Interval 1.8 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug to date of death from any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)Population: Full analysis set included all randomized participants.
OS was defined as the time (in months) from the date of first dose of study drug to the date of death due to any cause or data censoring date, whichever occurred first. Participants last known to be alive were censored at the date of last contact. OS was analyzed by Kaplan-Meier method.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=6 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=7 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=7 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
OS for Combination F
|
10.0 Months
Interval 2.2 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
11.7 Months
Interval 2.0 to
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
|
5.9 Months
Interval 3.0 to 7.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until disease progression or death due to any cause (maximum up to 7.3 years)Population: Full analysis set includes all randomized participants for Cohorts A1, A2, A3, A9, and A10 and all enrolled participants for Cohorts A4, A5, A6, A7, and A8 who received at least 1 dose of study drug.
OR as assessed by investigator per RECIST v.1.1, was defined as participants with confirmed best overall response of complete response (CR) or partial response (PR), were recorded from first dose of study drug until disease progression or death due to any cause. CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 mm. PR was defined as \>=30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=29 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=28 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=29 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b: Percentage of Participants With Objective Response (OR) for Combination A
|
3.4 Percentage of participants
Interval 0.1 to 17.8
|
0 Percentage of participants
Interval 0.0 to 12.3
|
10.3 Percentage of participants
Interval 2.2 to 27.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until disease progression or death due to any cause (maximum up to 7.3 years)Population: Full analysis set included all enrolled participants who received at least one dose of study drug.
OR as assessed by investigator per RECIST v.1.1, was defined as participants with confirmed best overall response of CR or PR, were recorded from first dose of study drug until disease progression or death due to any cause. CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 mm. PR was defined as \>=30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=12 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=8 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b: Percentage of Participants With Objective Response (OR) for Combination B
|
0 Percentage of participants
Interval 0.0 to 26.5
|
0 Percentage of participants
Interval 0.0 to 26.5
|
0 Percentage of participants
Interval 0.0 to 36.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until disease progression or death due to any cause (maximum up to 7.3 years)Population: Full analysis set included all enrolled participants who received at least one dose of study drug.
OR as assessed by investigator per RECIST v.1.1, was defined as participants with confirmed best overall response of CR or PR, were recorded from first dose of study drug until disease progression or death due to any cause. CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 mm. PR was defined as \>=30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=10 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=8 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=6 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b: Percentage of Participants With Objective Response (OR) for Combination C
|
10.0 Percentage of participants
Interval 0.3 to 44.5
|
25.0 Percentage of participants
Interval 3.2 to 65.1
|
16.7 Percentage of participants
Interval 0.4 to 64.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until disease progression or death due to any cause (maximum up to 7.3 years)Population: Full analysis set included all enrolled participants who received at least one dose of study drug.
OR as assessed by investigator per RECIST v.1.1, was defined as participants with confirmed best overall response of CR or PR, were recorded from first dose of study drug until disease progression or death due to any cause. CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 mm. PR was defined as \>=30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=12 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=12 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=12 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=11 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b: Percentage of Participants With Objective Response (OR) for Combination D
|
8.3 Percentage of participants
Interval 0.2 to 38.5
|
33.3 Percentage of participants
Interval 9.9 to 65.1
|
25.0 Percentage of participants
Interval 5.5 to 57.2
|
8.3 Percentage of participants
Interval 0.2 to 38.5
|
8.3 Percentage of participants
Interval 0.2 to 38.5
|
18.2 Percentage of participants
Interval 2.3 to 51.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until disease progression or death due to any cause (maximum up to 7.3 years)Population: Full analysis set included all randomized participants.
OR as assessed by investigator per RECIST v.1.1, was defined as participants with confirmed best overall response of CR or PR, were recorded from first dose of study drug until disease progression or death due to any cause. CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 mm. PR was defined as \>=30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=6 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=7 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=7 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b: Percentage of Participants With Objective Response (OR) for Combination F
|
0 Percentage of participants
Interval 0.0 to 45.9
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
0 Percentage of participants
Interval 0.0 to 41.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1)Population: The analysis population was a subset of the safety analysis set (all participants who received at least one dose of study drug) and included participants who had at least one biomarker parameter of PD-L1 and CD8+ lymphocytes from the corresponding assay sample with at least one baseline biomarker measurement. Here, ''Number Analyzed'' signifies number of participants evaluable for each specified row.
PD-L1 protein expression is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The specimen is considered to have PD-L1 expression if TPS \>=1% and high PD-L1 expression if TPS \>= 50%. Tumor infiltrating CD8+ lymphocytes is defined as the number of CD8+ cells per unit area and the percent of counted cells. Positive is defined as \>=1% and negative is defined as \<1%.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=24 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=24 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=22 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=22 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=24 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=18 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=8 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
n=18 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
n=9 Participants
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=8 Participants
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating Cluster of Differentiation 8 (CD8+) Lymphocytes at Baseline for Combination A
PD-L1
|
24 Participants
|
24 Participants
|
22 Participants
|
22 Participants
|
24 Participants
|
18 Participants
|
8 Participants
|
18 Participants
|
9 Participants
|
8 Participants
|
|
Number of Participants With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating Cluster of Differentiation 8 (CD8+) Lymphocytes at Baseline for Combination A
CD8+
|
24 Participants
|
24 Participants
|
22 Participants
|
21 Participants
|
24 Participants
|
18 Participants
|
8 Participants
|
18 Participants
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1)Population: The analysis population was a subset of the safety analysis set (all participants who received at least one dose of study drug) and included participants who had at least one biomarker parameter of PD-L1 and CD8+ lymphocytes from the corresponding assay sample with at least one baseline biomarker measurement.
PD-L1 protein expression is determined by using TPS, which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The specimen is considered to have PD-L1 expression if TPS \>=1% and high PD-L1 expression if TPS \>= 50%. Tumor infiltrating CD8+ lymphocytes is defined as the number of CD8+ cells per unit area and the percent of counted cells. Positive is defined as \>=1% and negative is defined as \<1%.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=4 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=8 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=4 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=10 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=19 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination B
PD-L1
|
4 Participants
|
8 Participants
|
4 Participants
|
10 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination B
CD8+
|
3 Participants
|
8 Participants
|
4 Participants
|
10 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1)Population: The analysis population was a subset of the safety analysis set (all participants who received at least one dose of study drug) and included participants who had at least one biomarker parameter of PD-L1 and CD8+ lymphocytes from the corresponding assay sample with at least one baseline biomarker measurement.
PD-L1 protein expression is determined by using TPS, which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The specimen is considered to have PD-L1 expression if TPS \>=1% and high PD-L1 expression if TPS \>= 50%. Tumor infiltrating CD8+ lymphocytes is defined as the number of CD8+ cells per unit area and the percent of counted cells. Positive is defined as \>=1% and negative is defined as \<1%.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=6 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=3 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=4 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination C
PD-L1
|
6 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination C
CD8+
|
6 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1)Population: The analysis population was a subset of the safety analysis set (all participants who received at least one dose of study drug) and included participants who had at least one biomarker parameter of PD-L1 and CD8+ lymphocytes from the corresponding assay sample with at least one baseline biomarker measurement.
PD-L1 protein expression is determined by using TPS, which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The specimen is considered to have PD-L1 expression if TPS \>=1% and high PD-L1 expression if TPS \>= 50%. Tumor infiltrating CD8+ lymphocytes is defined as the number of CD8+ cells per unit area and the percent of counted cells. Positive is defined as \>=1% and negative is defined as \<1%.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=9 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=8 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=11 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=10 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=10 Participants
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=10 Participants
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination D
PD-L1
|
9 Participants
|
8 Participants
|
11 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination D
CD8+
|
8 Participants
|
8 Participants
|
11 Participants
|
9 Participants
|
10 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1)Population: The analysis population was a subset of the safety analysis set (all participants who received at least one dose of study drug) and included participants who had at least one biomarker parameter of PD-L1 and CD8+ lymphocytes from the corresponding assay sample with at least one baseline biomarker measurement.
PD-L1 protein expression is determined by using TPS, which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The specimen is considered to have PD-L1 expression if TPS \>=1% and high PD-L1 expression if TPS \>= 50%. Tumor infiltrating CD8+ lymphocytes is defined as the number of CD8+ cells per unit area and the percent of counted cells. Positive is defined as \>=1% and negative is defined as \<1%.
Outcome measures
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=4 Participants
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=7 Participants
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=5 Participants
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination F
PD-L1
|
4 Participants
|
7 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination F
CD8+
|
4 Participants
|
7 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
Serious events: 11 serious events
Other events: 29 other events
Deaths: 18 deaths
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
Serious events: 12 serious events
Other events: 27 other events
Deaths: 19 deaths
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
Serious events: 13 serious events
Other events: 28 other events
Deaths: 20 deaths
Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab
Serious events: 9 serious events
Other events: 28 other events
Deaths: 19 deaths
Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab
Serious events: 16 serious events
Other events: 33 other events
Deaths: 25 deaths
Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab
Serious events: 4 serious events
Other events: 20 other events
Deaths: 12 deaths
Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab
Serious events: 4 serious events
Other events: 10 other events
Deaths: 6 deaths
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
Serious events: 8 serious events
Other events: 21 other events
Deaths: 14 deaths
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
Serious events: 4 serious events
Other events: 11 other events
Deaths: 7 deaths
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
Serious events: 1 serious events
Other events: 10 other events
Deaths: 6 deaths
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab
Serious events: 3 serious events
Other events: 12 other events
Deaths: 7 deaths
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab
Serious events: 4 serious events
Other events: 12 other events
Deaths: 6 deaths
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab
Serious events: 1 serious events
Other events: 8 other events
Deaths: 6 deaths
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab
Serious events: 3 serious events
Other events: 14 other events
Deaths: 8 deaths
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab
Serious events: 10 serious events
Other events: 25 other events
Deaths: 21 deaths
Combination C Phase 1b: PD 0360324 50 mg + Avelumab
Serious events: 4 serious events
Other events: 9 other events
Deaths: 5 deaths
Combination C Phase 1b: PD 0360324 100 mg + Avelumab
Serious events: 3 serious events
Other events: 8 other events
Deaths: 4 deaths
Combination C Phase 1b: PD 0360324 150 mg + Avelumab
Serious events: 4 serious events
Other events: 6 other events
Deaths: 4 deaths
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab
Serious events: 2 serious events
Other events: 12 other events
Deaths: 9 deaths
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab
Serious events: 3 serious events
Other events: 11 other events
Deaths: 7 deaths
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab
Serious events: 4 serious events
Other events: 12 other events
Deaths: 7 deaths
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
Serious events: 5 serious events
Other events: 11 other events
Deaths: 8 deaths
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
Serious events: 4 serious events
Other events: 12 other events
Deaths: 10 deaths
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
Serious events: 5 serious events
Other events: 11 other events
Deaths: 7 deaths
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab
Serious events: 2 serious events
Other events: 5 other events
Deaths: 4 deaths
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg
Serious events: 4 serious events
Other events: 7 other events
Deaths: 5 deaths
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg
Serious events: 4 serious events
Other events: 7 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=29 participants at risk
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=27 participants at risk
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=29 participants at risk
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab
n=28 participants at risk
During Phase 2 participants with melanoma received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab
n=35 participants at risk
During Phase 2 participants with Squamous Cell Carcinoma of the Head and Neck (SCCHN) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab
n=21 participants at risk
During Phase 2 participants with Triple Negative Breast Cancer (TNBC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab
n=10 participants at risk
During Phase 2 participants with Squamous cell lung cancer (SCLC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
n=21 participants at risk
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
n=11 participants at risk
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=11 participants at risk
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab
n=12 participants at risk
During Phase 1b participants received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
|
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab
n=12 participants at risk
During Phase 1b participants received PF-04518600 1.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
|
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab
n=8 participants at risk
During Phase 1b participants received PF-04518600 3.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
|
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab
n=14 participants at risk
During Phase 2 participants with NSCLC received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
|
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab
n=25 participants at risk
During Phase 2 participants with SCCHN received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
|
Combination C Phase 1b: PD 0360324 50 mg + Avelumab
n=10 participants at risk
During Phase 1b participants received PD 0360324 50 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination C Phase 1b: PD 0360324 100 mg + Avelumab
n=8 participants at risk
During Phase 1b participants received PD 0360324 100 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination C Phase 1b: PD 0360324 150 mg + Avelumab
n=6 participants at risk
During Phase 1b participants received PD 0360324 150 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab
n=12 participants at risk
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 0.1 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab
n=12 participants at risk
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.1 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab
n=12 participants at risk
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=12 participants at risk
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=12 participants at risk
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=11 participants at risk
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab
n=6 participants at risk
During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 sub-cutaneous \[SC\] administered at weekly intervals, followed by 5 intra tumoral \[IT\] administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W. Phase 2 was not planned.
|
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg
n=7 participants at risk
During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus utomilumab 100 mg administered IV Q4W. Phase 2 was not planned.
|
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg
n=7 participants at risk
During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus PF-04518600 at 0.3 mg/kg administered IV Q2W. Phase 2 was not planned.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Cardiac disorders
Angina pectoris
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Asthenia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Disease progression
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.8%
4/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Fatigue
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Inflammation
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Non-cardiac chest pain
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Hepatobiliary disorders
Bile duct stone
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Fungaemia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Lower respiratory tract infection
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Phlebitis infective
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Pneumonia
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Wound infection
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncologic complication
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.0%
2/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Vascular disorders
Flushing
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Vascular disorders
Hypertension
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Eye disorders
Blindness
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Oesophageal fistula
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Vascular disorders
Embolism
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Oral cavity fistula
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Death
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Troponin increased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of head and neck
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Pain
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis aspiration
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Vascular disorders
Haematoma
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
Other adverse events
| Measure |
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
n=29 participants at risk
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
n=27 participants at risk
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
n=29 participants at risk
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab
n=28 participants at risk
During Phase 2 participants with melanoma received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab
n=35 participants at risk
During Phase 2 participants with Squamous Cell Carcinoma of the Head and Neck (SCCHN) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab
n=21 participants at risk
During Phase 2 participants with Triple Negative Breast Cancer (TNBC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab
n=10 participants at risk
During Phase 2 participants with Squamous cell lung cancer (SCLC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
n=21 participants at risk
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
n=11 participants at risk
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
n=11 participants at risk
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
|
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab
n=12 participants at risk
During Phase 1b participants received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
|
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab
n=12 participants at risk
During Phase 1b participants received PF-04518600 1.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
|
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab
n=8 participants at risk
During Phase 1b participants received PF-04518600 3.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
|
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab
n=14 participants at risk
During Phase 2 participants with NSCLC received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
|
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab
n=25 participants at risk
During Phase 2 participants with SCCHN received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
|
Combination C Phase 1b: PD 0360324 50 mg + Avelumab
n=10 participants at risk
During Phase 1b participants received PD 0360324 50 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination C Phase 1b: PD 0360324 100 mg + Avelumab
n=8 participants at risk
During Phase 1b participants received PD 0360324 100 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination C Phase 1b: PD 0360324 150 mg + Avelumab
n=6 participants at risk
During Phase 1b participants received PD 0360324 150 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab
n=12 participants at risk
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 0.1 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab
n=12 participants at risk
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.1 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab
n=12 participants at risk
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
n=12 participants at risk
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
n=12 participants at risk
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
n=11 participants at risk
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
|
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab
n=6 participants at risk
During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 sub-cutaneous \[SC\] administered at weekly intervals, followed by 5 intra tumoral \[IT\] administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W. Phase 2 was not planned.
|
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg
n=7 participants at risk
During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus utomilumab 100 mg administered IV Q4W. Phase 2 was not planned.
|
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg
n=7 participants at risk
During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus PF-04518600 at 0.3 mg/kg administered IV Q2W. Phase 2 was not planned.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.8%
4/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
17.1%
6/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
27.3%
3/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
2/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
42.9%
3/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Cardiac disorders
Bradycardia
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Cardiac disorders
Sinus tachycardia
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Cardiac disorders
Tachycardia
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.8%
4/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
3/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Fatigue
|
34.5%
10/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
51.9%
14/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
41.4%
12/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
39.3%
11/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
22.9%
8/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
3/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
30.0%
3/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
42.9%
9/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
63.6%
7/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
36.4%
4/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
58.3%
7/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
41.7%
5/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
2/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
4/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.0%
7/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
30.0%
3/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
2/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
41.7%
5/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
41.7%
5/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
50.0%
6/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
41.7%
5/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
50.0%
6/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
83.3%
5/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
57.1%
4/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
85.7%
6/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.0%
2/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
13.8%
4/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
5/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
27.3%
3/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.0%
2/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Eye disorders
Cataract
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Eye disorders
Diplopia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Eye disorders
Dry eye
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Eye disorders
Eye irritation
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
2/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Eye disorders
Vision blurred
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
2/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.8%
4/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.4%
2/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
17.9%
5/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
19.0%
4/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
2/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.0%
4/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
27.3%
3/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Constipation
|
13.8%
4/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.8%
4/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
27.6%
8/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
8/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
17.1%
6/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
3/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.0%
2/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
23.8%
5/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
27.3%
3/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
4/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
2/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.0%
5/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
2/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
4/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
71.4%
5/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.7%
6/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.5%
5/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.7%
6/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
17.9%
5/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.0%
7/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
19.0%
4/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.0%
2/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
6/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
27.3%
3/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
50.0%
4/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
42.9%
6/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.0%
4/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.0%
2/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
2/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
41.7%
5/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
4/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
50.0%
3/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
57.1%
4/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Dry mouth
|
10.3%
3/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.5%
5/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.7%
3/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.0%
3/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
2/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
42.9%
3/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.3%
3/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
11.1%
3/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.6%
3/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Lip disorder
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Nausea
|
27.6%
8/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
9/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
24.1%
7/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
8/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
19.0%
4/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
30.0%
3/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
42.9%
9/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
45.5%
5/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
27.3%
3/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
41.7%
5/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
4/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
24.0%
6/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.0%
2/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
37.5%
3/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
50.0%
3/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
27.3%
3/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
66.7%
4/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
42.9%
3/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
3/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Vomiting
|
20.7%
6/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.9%
7/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
17.2%
5/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
21.4%
6/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.0%
7/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
6/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
19.0%
4/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
36.4%
4/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
4/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
2/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
35.7%
5/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.0%
3/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
30.0%
3/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
2/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
66.7%
4/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
4/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
27.3%
3/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
50.0%
3/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Asthenia
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
11.1%
3/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
17.2%
5/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
5/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
2/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Catheter site pain
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Chest discomfort
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Chest pain
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Chills
|
13.8%
4/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.8%
4/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
4/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
11.4%
4/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
23.8%
5/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
6/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
36.4%
4/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
21.4%
3/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.0%
3/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.0%
2/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
2/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
42.9%
3/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
57.1%
4/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Early satiety
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Face oedema
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Feeling hot
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Gait disturbance
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.3%
3/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Ill-defined disorder
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Influenza like illness
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
3/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.0%
2/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Injection site pain
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
2/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Localised oedema
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Malaise
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
2/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Non-cardiac chest pain
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
27.3%
3/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
2/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Oedema peripheral
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.4%
2/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
13.8%
4/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.0%
2/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
2/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Pain
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.7%
3/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.0%
2/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.0%
2/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
2/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Peripheral swelling
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Pyrexia
|
10.3%
3/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
11.1%
3/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
13.8%
4/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.7%
3/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
5/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
19.0%
4/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.0%
2/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
21.4%
3/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
2/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Swelling
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.0%
2/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Swelling face
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Temperature intolerance
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
13.8%
4/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Candida infection
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Eye infection
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Fungal foot infection
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Furuncle
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Lip infection
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Nail infection
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.7%
3/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.0%
2/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Oral candidiasis
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Otitis media
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Paronychia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Pneumonia
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.4%
2/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.0%
3/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.0%
2/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Skin infection
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.0%
2/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.3%
3/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.5%
5/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
3/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.4%
2/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.7%
3/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Viral infection
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.4%
2/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Fall
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.8%
4/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
13.8%
4/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.0%
2/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
19.0%
4/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
27.3%
3/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
2/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.0%
2/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
34.5%
10/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.8%
4/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
24.1%
7/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.7%
3/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.6%
3/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
3/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.0%
2/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
4/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
2/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
2/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
2/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
4/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
27.3%
3/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
2/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Endocrine disorders
Secondary hypogonadism
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Eye disorders
Eye oedema
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Eye disorders
Photophobia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Eye disorders
Visual field defect
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Eye disorders
Visual impairment
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Eye disorders
Blepharitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Eye disorders
Eye swelling
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Eye disorders
Pterygium
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Tooth discolouration
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Application site rash
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Catheter site related reaction
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Facial pain
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Necrosis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Induration
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Axillary pain
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Hernia pain
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Impaired healing
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Medical device site burn
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Injection site nodule
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
General disorders
Injection site reaction
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
42.9%
3/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
42.9%
3/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Pilonidal disease
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Herpes dermatitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Penile infection
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Tracheostomy malfunction
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Alanine aminotransferase increased
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
3/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
27.3%
3/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
2/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Amylase increased
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.0%
2/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Aspartate aminotransferase increased
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
11.1%
3/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
11.4%
4/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
3/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
36.4%
4/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
2/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Blood calcium increased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.6%
3/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.0%
2/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.4%
2/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.0%
2/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Blood pressure increased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.3%
3/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.6%
3/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Lipase increased
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.8%
4/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
17.9%
5/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.0%
2/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
42.9%
6/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.0%
3/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Platelet count decreased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Weight decreased
|
10.3%
3/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.5%
5/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
13.8%
4/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.6%
3/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
30.0%
3/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
27.3%
3/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
37.5%
3/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
4/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Weight increased
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.2%
5/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
11.1%
3/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
31.0%
9/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
5/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
19.0%
4/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
60.0%
6/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
6/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
27.3%
3/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
37.5%
3/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
35.7%
5/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
24.0%
6/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
30.0%
3/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
37.5%
3/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
27.3%
3/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.3%
3/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.8%
4/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
17.2%
5/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.0%
2/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.0%
2/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.8%
4/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.6%
3/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
50.0%
3/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.3%
3/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
13.8%
4/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.7%
3/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
5/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
3/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
30.0%
3/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.4%
2/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.6%
3/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.0%
2/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.0%
3/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
2/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
13.8%
4/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
2/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.1%
7/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.8%
4/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
13.8%
4/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.7%
3/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.6%
3/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
19.0%
4/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
23.8%
5/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
36.4%
4/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
36.4%
4/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
21.4%
3/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.0%
3/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
2/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
4/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
34.5%
10/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
11.1%
3/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.3%
3/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
17.9%
5/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
11.4%
4/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
7/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
19.0%
4/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
27.3%
3/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
45.5%
5/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
2/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.0%
2/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
42.9%
3/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
2/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
13.8%
4/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.3%
3/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.3%
3/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.3%
3/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
3/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.0%
3/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.4%
2/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.4%
2/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.0%
4/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.3%
3/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
11.1%
3/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.3%
3/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
19.0%
4/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.0%
2/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.7%
3/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
5/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
19.0%
4/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
2/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
2/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.3%
3/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
11.1%
3/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.3%
3/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
3/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
36.4%
4/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
21.4%
3/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
42.9%
3/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
11.4%
4/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Brain oedema
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Dizziness
|
10.3%
3/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
11.1%
3/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.3%
3/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
5/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
3/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.0%
4/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
37.5%
3/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Dysgeusia
|
10.3%
3/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
3/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Headache
|
17.2%
5/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
22.2%
6/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
11.4%
4/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
3/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
36.4%
4/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
36.4%
4/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
24.0%
6/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
37.5%
3/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
2/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
41.7%
5/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
41.7%
5/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
27.3%
3/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
2/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Intention tremor
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.6%
3/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.0%
2/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Paraesthesia
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.0%
2/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
2/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Psychiatric disorders
Anxiety
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
2/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Psychiatric disorders
Depression
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.0%
3/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Psychiatric disorders
Insomnia
|
10.3%
3/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
13.8%
4/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.0%
2/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
35.7%
5/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.0%
2/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
37.5%
3/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
2/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Renal and urinary disorders
Haematuria
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.0%
2/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Renal and urinary disorders
Pollakiuria
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
2/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.8%
4/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
11.1%
3/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
27.6%
8/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
5/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
3/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
19.0%
4/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
45.5%
5/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
2/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.0%
2/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.0%
2/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
4/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
4/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.7%
6/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
22.2%
6/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
27.6%
8/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.0%
7/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
19.0%
4/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
40.0%
4/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
19.0%
4/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
45.5%
5/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
45.5%
5/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
50.0%
7/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.0%
5/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
30.0%
3/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
2/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
2/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
2/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
10.3%
3/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.0%
2/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.6%
3/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
13.8%
4/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
11.1%
3/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.0%
3/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
2/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.0%
2/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.4%
2/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Blood glucose increased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Body temperature increased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Cardiac murmur
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Liver function test increased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Lymph node palpable
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Urine output decreased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Amylase
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Blood creatine phosphokinase
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Blood corticotrophin decreased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Blood corticotrophin increased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Blood urea increased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
Pancreatic enzymes increased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.0%
2/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Product Issues
Device occlusion
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Dysmetria
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Dizziness exertional
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Superior sagittal sinus thrombosis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Tremor
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Psychiatric disorders
Stress
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Psychiatric disorders
Anticipatory anxiety
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Reproductive system and breast disorders
Testicular swelling
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Reproductive system and breast disorders
Peyronie's disease
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of bronchial secretion
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Lung opacity
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngeal reflux
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis aspiration
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.8%
4/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
3/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
24.1%
7/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.9%
7/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
4/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
11.4%
4/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
3/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
30.0%
3/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
27.3%
3/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
2/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.0%
4/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
2/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
4/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
41.7%
5/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.3%
3/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.8%
4/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
4/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
27.3%
3/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
2/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.0%
3/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
4/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
18.2%
2/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.4%
2/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
27.3%
3/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
2/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
25.0%
3/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary pain
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
2/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
33.3%
2/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Butterfly rash
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Nail pitting
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Surgical and medical procedures
Sinus operation
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Vascular disorders
Flushing
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.5%
2/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Vascular disorders
Hot flush
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.8%
1/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
2/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.0%
3/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Vascular disorders
Hypertension
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.4%
1/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
2/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
5.7%
2/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
3/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
14.3%
1/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Vascular disorders
Hypotension
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.7%
1/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
6.9%
2/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
3.6%
1/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
2.9%
1/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
20.0%
2/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
4.0%
1/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
2/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
28.6%
2/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
7.1%
1/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
10.0%
1/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Vascular disorders
Haematoma
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
9.1%
1/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Vascular disorders
Scalp haematoma
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
16.7%
1/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/27 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/29 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/28 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/35 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/21 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/14 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/25 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/10 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
12.5%
1/8 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
8.3%
1/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/12 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/11 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/6 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
0.00%
0/7 • Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER